CBD Oil Dosing Pediatrics

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Benefits of CBD use for children include the treatment of epilepsy, anxiety, and high blood pressure. But what about the dosage? Let's discuss it here. We outline whether or not it's safe to use CBD oil with your youngsters, as well as outline our favorite CBD oil for kids brands in this comprehensive guide. Initial studies suggest pharmaceutical grade cannabidiol (CBD) can reduce the frequency of convulsive seizures and lead to improvements in quality of life in children affected by epileptic encephalopathies. With limited access to pharmaceutical CBD, Cannabis extracts in oil are becoming increasingly available. Physicians show reluctance to recommend Cannabis extracts given the lack of high quality safety data especially regarding the potential for harm caused by other cannabinoids, such as Δ9-tetrahydrocannabinol (Δ9-THC). The primary aims of the study presented in this protocol are (i) To determine whether CBD enriched Cannabis extract is safe and well-tolerated for pediatric patients with refractory epilepsy, (ii) To monitor the effects of CBD-enriched Cannabis extract on the frequency and duration of seizure types and on quality of life. Twenty-eight children with treatment resistant epileptic encephalopathy ranging in age from 1 to 10 years will be recruited in four Canadian cities into an open-label, dose-escalation phase 1 trial. The primary objectives for the study are (i) To determine if the CBD-enriched Cannabis herbal extract is safe and well-tolerated for pediatric patients with treatment resistant epileptic encephalopathy and (ii) To determine the effect of CBD-enriched Cannabis herbal extract on the frequency and duration of seizures. Secondary objectives include (i) To determine if CBD-enriched Cannabis herbal extracts alter steady-state levels of co-administered anticonvulsant medications. (ii) To assess the relation between dose escalation and quality of life measures, (iii) To determine the relation between dose escalation and steady state trough levels of bioactive cannabinoids. (iv) To determine the relation between dose escalation and incidence of adverse effects. This paper describes the study design of a phase 1 trial of CBD-enriched Cannabis herbal extract in children with treatment-resistant epileptic encephalopathy. This study will provide the first high quality analysis of safety of CBD-enriched Cannabis herbal extract in pediatric patients in relation to dosage and pharmacokinetics of the active cannabinoids. http://clinicaltrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2016 Dec 16. Identifier NCT03024827, Cannabidiol in Children with Refractory Epileptic Encephalopathy: CARE-E; 2017 Jan 19 [cited 2017 Oct]; Available from: http://clinicaltrials.gov/ct2/show/NCT03024827

What Is the Correct CBD Dose for Kids?

Although proven beneficial, CBD products are something parents often hesitate to administer to their children. While the majority of states have legalized full-spectrum CBD usage, some negative connotations remain attached to these products.

We assure you that CBD oil is beneficial to kids and adults alike. Medicinal benefits of CBD use for children include the treatment of pediatric epilepsy, anxiety, and high blood pressure.

SUPA Naturals aims to enlighten people about CBD’s positive effects by providing top-notch medical cannabis products. We have years of experience in developing and distributing CBD products without adverse effects.

Contact us anytime regarding your questions about CBD oil for children.

What Is CBD?

CBD is a principal ingredient in the cannabis Sativa plant. It comes from hemp, which also contains a small amount of THC.

THC is more potent than CBD and therefore can lead to trippy effects such as hallucination. Unfortunately, cannabis haze is what many people immediately think of when learning of how CBD is derived from hemp. However, CBD is much safer than THC to use on infants and children.

CBD usage increases each year as more countries continue to legalize marijuana and hemp products. CBD will likely be legal in more countries than any other hemp product due to its safety and medical application.

CBD appeals to many people because it does not make you feel high like other hemp or marijuana products. You get most of the benefits of these products while avoiding the aloofness that comes with them.

CBD products offer many medical benefits for your child. Each year, we learn more about CBD and its effects on the body. However, we can assure you that it is safe for your child to consume and aids them in dealing with anxiety, pain, and many medical conditions.

How CBD Oil Benefits Your Child

While many adults use CBD products to relieve joint pain, recover from workouts, and calm their nerves, most children have different reasons for applying cannabis oil.

Pediatric Epilepsy

One of the principal reasons for the recent growth in the medical marijuana market is because CBD use can curb pediatric epilepsy. This condition was the catalyst for change in the cannabis naysayers’ perspective on CBD.

Medical studies show that CBD oil reduces the severity and frequency of seizures in epilepsy patients. If your child has pediatric epilepsy, consult with their physician about utilizing CBD oil as a potential remedy.

Your doctor must prescribe CBD for your child’s epilepsy before you use it.

Immune System Strengthening

If your child suffers from a compromised immune system, you must seek out any treatments or supplements that may help them. CBD provides necessary nourishment for your child, and many users praise its ability to improve their immune system.

Also, the properties of CBD oil contain fungi-fighting ingredients that help defend against many different types of bacteria.

Tame Anxiety

Unfortunately, anxiety affects millions of Americans each year. With stress comes a flurry of other medical conditions such as high blood pressure, migraines, and many others.

Perhaps the most common reason people use cannabis products is to lower their anxiety. CBD oil ingredients help mitigate the effects of stress and improve your child’s focus and help them remain calm throughout the day.

Many parents feel anxious when recalling stressful times from their youth. Now, you can help your child avoid those overwhelming moments with proper CBD dosage.

Autism

While medical experts are still researching the effects of CBD oil on children with autism, all signs point to a positive correlation.

A recent medical trial treated over 60 children with autism with CBD products. After the trial period, over 80% of the patients’ parents claim they saw improvements in their child’s condition. And over 60% of parents characterize the effects of CBD as ‘drastic.’

Mood Boost

In lighter terms, many parents use CBD oils on their kids to help improve their daily lives. Medical studies show that CBD ingredients are active in facilitating a mood boost.

Having a positive attitude is one of the best ways your son or daughter can live life. This mood boost will lead to better performance in school and athletics.

CBD Dose Titration for Children

Once you decide to move forward with CBD treatment for your child, you must research the correct CBD dose for kids. You want to give your children a sufficient CBD dose according to the needs of their condition.

Note that you cannot overdose on CBD, especially with an oil product. Still, it is wise to find the optimal dosage for your child.

Firstly, you should know that CBD is non-psychoactive, meaning your child will not face any hallucinogenic effects from consuming it. Because of this component, CBD oil is 100% safe for children.

Always consult a medical professional before starting your child on CBD products. While they are safe, your child may be allergic to particular ingredients in cannabis. Also, doctors may prescribe another treatment type for your child’s condition.

The best rule of thumb for pediatric CBD dosage is to begin with 0.5 milligrams per pound of bodyweight. You should apply the appropriate dosage approximately three times per day.

Therefore, if your child is thirty pounds, you should supply them with two drops of oil three times a day. If you want to be cautious with your child’s cannabis use, then you can start with a lower dose. Typically, children easily tolerate the 0.5-milligram dosage.

During the first couple of weeks of CBD therapy, you should watch for adverse effects. In most cases, however, there will be none.

If your child responds well to the cannabis product, you may increase the dosage to four drops of CBD oil three times a day. However, before you decide to increase your child’s dosage, consult a medical professional. Giving your kid a higher dosage comes with a minimal chance of side effects.

If your child has pediatric epilepsy, your doctor will recommend a unique dose that could be five to ten times more powerful than the average dosage. Your doctor will ensure that you are using the exact prescribed amount of CBD.

How To Use CBD Oil

Now that you know the proper CBD dose for kids, let’s discuss applying it correctly. There are many ways to consume CBD and THC products, including candles, vaping, sprays, and more.

However, the most common way for kids to ingest CBD is under their tongue. CBD application under your child’s tongue is recommended because the membranes there allow cannabis ingredients to absorb into the bloodstream immediately. If you are new to CBD, Try SUPA Natural’s CBD Oil.

CBD oils will taste like a marijuana strain in most cases. However, there are always new flavors coming to the market. Many users claim peppermint-flavored oils are preferable if your child does not like the taste of traditional CBD oil.

You may also consume CBD oil by mixing it with a beverage such as tea or milk. Do not mix CBD oil with water, though, as the oil will stick to the side of the glass. Also, many experts recommend that you give your child a high-fat snack in order to increase the amount of CBD they ingest.

There is another home trick CBD users recommend. You can place the CBD oil on a chocolate chip and let your child suck on the oil-drenched chip until it melts. This remedy eliminates the oil’s bitter weed taste.

Medical Facts

There are many annual medical studies on CBD oil and its effects. Here are some of the reports supporting the efficacy of CBD products.

Approved Treatment for Medical Conditions

The United States Food and Drug Administration and the European Medicines Agency approve the use of CBD products to treat Dravet syndrome, Lennox-Gastaut syndrome, and neonatal asphyxia.

Their studies show there are more benefits than disadvantages to using CBD oil on your newborn or adolescent. It takes an abundance of evidence for the FDA to approve a drug for consumption, indicating that they conclude low risk in using CBD for treatment purposes.

It Is Not Addictive

One of the most common misconceptions associated with hemp products is that they are addictive. Statements from the World Health Organization debunk this myth.

The WHO claims that there is no substantial evidence to suggest that CBD has anything in common with nicotine or other addictive drugs.

Its Legality Is Inevitable

While some states have restrictions on CBD use, CBD is legal in every state. The Farm Bill establishes that hemp is legal in the United States.

This legislation ensures that CBD oil will be legal for future products and use.

MS Remedy

Currently on the market is a CBD nasal spray that many claims to be helpful toward counteracting multiple sclerosis. Studies are ongoing as to the validity of these claims, but the forthcoming evidence is promising.

Some MS patients notice improvements in relaxing their muscle tightness and relieving pain, while others disagree.

Frequently Asked Questions

Naturally, we receive many questions regarding our cannabis products and their effects on children. Here are some of the most common questions our customers ask our management team.

Is it Legal to Use CBD on My Children?

Each state has its own policies regarding the legality of herb-based CBD products. In Washington State, CBD oil is legal to purchase.

THC use is where legality becomes tricky. However, CBD is within your right to purchase for your kids. Typically, your child’s doctor will involve themselves in the process by writing out a prescription.

Is CBD Safe for My Kids?

CBD oil is among the safest cannabis products that you can use on your child. It is impossible to overdose on CBD oils, while the chances of adverse side effects are minimal.

If you are trepidatious about giving your kids CBD oil, you can start with a low dosage to see how they react. Your child’s pediatrician can answer most of your questions about your kid’s cannabis usage. Also, we are here 24/7 to answer your questions.

How Old Do You Have to Be to Buy CBD Oil?

You must be at least eighteen years of age to purchase CBD products in Washington State. To be legal to distribute, a cannabis product cannot contain more than 0.3% THC.

Also, you should note that you cannot bring a marijuana product from another state into Washington. Any CBD oil that you purchase must originate from the Evergreen State.

How Will CBD Make My Kids Feel?

One of the first things that you will most likely notice when giving your children CBD is a sense of calmness. This effect is the most powerful of CBD oil.

With that increased calmness comes many additional benefits such as lower blood pressure, anxiety, and depression. If your child is using medical cannabis to treat an underlying condition, their doctor should supervise them to ensure that the treatment is going according to plan.

Does CBD Work for Anxiety?

The most proven benefit of CBD use is to cure stress. This effect is the most well-known effect of marijuana products. Stress and anxiety can be crippling for a child.

Luckily, today more CBD products than ever can quell your kid’s anxiety. You can start your kid on a minimum dosage to see how they react to CBD therapy.

Shop SUPA Products

As you can see, there are many benefits of using cannabis products on your children. You can help reduce your kid’s stress and treat critical medical conditions such as pediatric epilepsy.

If you want to use CBD for less severe conditions, such as minor pain relief, you should consult your doctor. The more your pediatrician gets involved, the more your chances improve of avoiding adverse side effects.

If you believe your child would benefit from using CBD oil and your child’s pediatrician agrees, we can help you by recommending the best CBD dose for kids. Our team knows the many aspects of CBD dosage and will happily address all your concerns.

Visit SUPA Naturals website or email us at [email protected] for more info!

CBD Oil for Kids: Is It Safe for Children with ADHD & Anxiety?

If you’re a parent, you’ll go above and beyond to keep your child healthy.

You may have heard your friends saying they’re using CBD oil with their kids. If you don’t know what CBD is, don’t worry — I’ll explain everything in this article, including why you may want to consider using the supplement with your children too.

Long story short, CBD stands for cannabidiol, a natural compound in cannabis plants with an array of positive effects on the body and brain but is non-psychoactive, unlike THC.

CBD is becoming increasingly popular for various negative symptoms, from anxiety to pain and inflammation (read more here).

It comes in many different forms, including CBD oil, capsules, edibles, beverages, vaping liquids, and topical products.

But which CBD oil will be the best for your little one?

In this guide, you’ll learn about 3 brands that, I believe, deserve your attention as a parent.

I’ve also mapped out several areas where CBD oil appears to be particularly effective, as well as what to look for when searching for the best CBD oil products for kids.

How to Find the CBD Oil for Your Kids

Several steps are involved in the production of CBD oil; each of them is a make-or-break factor.

Quality is paramount when buying CBD oil for kids, so if you want to rest assured your money goes in the right hands, I suggest researching the following information:

1. Hemp Source

It all starts in the soil.

Hemp is an effective bioaccumulator. What does this mean?

It means it absorbs everything from the environment it’s cultivated in.

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In essence, when grown in clean and fertile soil, hemp will pull all the good nutrients to grow strong, healthy, and produce plenty of CBD.

But when the growing conditions are inferior and the soil polluted, the plant will draw every contaminant, resulting in very poor sourcing material.

With that said, I strongly recommend buying CBD from domestic farmers who grow organic hemp plants, even if they aren’t certified organic.

This ensures you’ll only get pure CBD oil that is safe for your kid.

2. Extraction Method

The method by which CBD oil is processed can tell much about its quality.

Some manufacturers use toxic solvents like propane and butane for extraction to avoid higher production costs and sell cheap CBD oil. The toxic residue in such products is what you want to steer clear of. I, for example, couldn’t imagine myself purposefully exposing my children to hazardous substances.

Two extraction methods yield clean and potent extracts without leaving any harmful chemicals behind — Ethanol and CO2 extraction.

Ethanol is used in making CBD tinctures. The high-CBD bud is soaked in high-proof alcohol like Ethanol, so the cannabinoids and other hemp compounds can be extracted.

CO2 extraction calls for using pressurized CO2 at varying temperatures to obtain an oily extract suspended in a carrier oil (most often MCT oil). This method is the golden standard in the industry.

3. Is It Full-Spectrum CBD Oil or Isolate?

Full-spectrum CBD oil contains all phytonutrients from hemp, including cannabinoids (with trace amounts of THC), terpenes, flavonoids, and essential oils, whereas CBD isolate carries only pure, isolated cannabidiol.

While isolates offer the highest dose of CBD per serving and are more versatile than full-spectrum CBD (it has no odor and no flavor), it lacks the synergy achieved by other hemp compounds in the full-spectrum extract.

CBD oil obtained from the whole plant is believed to have a greater therapeutic value than isolate-based products, and the user needs less CBD to achieve the desired effect. More scientific evidence supports the theory about the synergy between cannabinoids, especially when it comes to pain and inflammation.

I, too, believe that full-spectrum CBD oil is a better choice, but if your child is allergic to certain constituents of the hemp plant — or you don’t want even a negligible amount of THC in their system — isolates might be your only option.

4. Third-party Testing & Lab Results

Once a CBD oil is manufactured, companies can submit their products for third-party testing conducted by non-company staff to ensure the product is safe for consumption and consistent with the bottle’s label.

CBD oils should always feature information about third-party tests; if they don’t, it should raise some red flags.

It’s all the better if the actual lab results accompany that information. As a rule of thumb, companies that include lab results are generally better than those that aren’t open about them.

When buying CBD oil for your kid, it’s essential to choose the one that will suit their dosage needs. I would always go for the lower potency with children unless there’s a specific reason you want to give them CBD.

CBD Oil Effects on Kids

CBD has coined its fame thanks to its anticonvulsant properties in children with rare forms of epilepsy. Still, this cannabinoid can also alleviate less severe conditions, too — not to mention it’s a great supplement to keep your little pumpkin in good health in a natural way.

Below I go over the most common uses of CBD oil in kids and how it may improve selected health problems. Keep in mind that both the amount of CBD intake and the time of the day can affect how your kid responds to CBD oil.

CBD Oil for Kids With ADHD

If your child has an attention disorder — they quickly get overstimulated and have problems maintaining focus — CBD can help with symptom management.

Research on CBD as a potential treatment for ADHD is sparse. We know most of what we know about the link between these two stems from studies on cannabis as a whole, not the specific CBD compound.

However, there’s a lot of anecdotal evidence from parents giving CBD to their kids that CBD oil helps manage their hyperactivity symptoms.

Moreover, a 2014 study published in Current Neuropharmacology suggests that CBD can be a wake-promoting agent at low doses, making users more alert throughout the day (1).

Interestingly, our sleep-wake cycle largely depends on our level of alertness during the day, so CBD oil may also help when your kiddo has problems falling asleep at night.

CBD Oil for Kids With Anxiety

CBD exerts several actions in the brain that regulate our brain’s response to feelings of fear and anxiety. The research in this subject is mostly preclinical or based on animal studies, but there are thousands of testimonies from parents whose children found relief from anxiety in CBD oil.

But how exactly does CBD work for anxiety disorders?

Research suggests that cannabidiol inhibits serotonin reuptake in the brain. In other words, it makes serotonin more available for the body (2). With better control of your serotonin resources, CBD could help stabilize mood and reduce anxiety.

The second benefit is associated with CBD’s ability to prompt the endocannabinoid system to produce more natural cannabinoids (3). This includes anandamide — the endocannabinoid regulating emotions such as fear, bliss, and euphoria.

Insufficient anandamide production has been linked to low mood or overreaction to anxiety triggers.

As with serotonin, CBD stimulates the release of anandamide and helps it stay in the body for a longer duration — assisting the user in maintaining sanity.

Last but not least, CBD may stimulate the hippocampus (a critical brain area playing a vital role in an array of brain functions) to regenerate neurons (4). These findings are particularly interesting because brain scans of patients suffering from anxiety and depression often show a smaller hippocampus.

CBD Oil for Kids With Autism

A study led by the director of pediatric neurology at Jerusalem’s Shareek Zedek Hospital, Dr. Adi Aran, treated 60 autistic children with CBD oil for at least seven months.

After the treatment period, parents were asked to fill out assessment questionnaires about changes in their child’s condition. The researchers asked questions about behavioral changes, anxiety levels, and communication skills.

According to the collected data, 80% of parents noted a decline in problematic behaviors, with 62% reporting great improvements. Half of the examined children showed improved communication, and 40% of parents reported significant decreases in their children’s anxiety (5).

While these are some really promising results, we need more longitudinal studies on larger groups of patients for the research to be conclusive.

Top 4 CBD Oil Brands

I’ve tested plenty of CBD brands in my life, and I have a list of my personal favorites. It turns out that three of them are a perfect match for my children’s needs.

I always base my product recommendations on extensive testing and thousands of verified customer reviews to give you a full picture of any given product I tackle. I would never suggest any product that fails to meet my quality and safety criteria.

Below you’ll find the top 4 brands selling CBD oil.

1. Royal CBD (Best Overall)

Get 15% off all Royal CBD products. Use code “CFAH” at checkout.

Pros:

  • Full-spectrum of phytocannabinoids
  • Made from 100% natural ingredients
  • Extracted with supercritical CO2
  • Contained in premium-quality MCT oil
  • Lab-tested for potency and purity
  • The 500mg bottle is easy to dose
  • They also sell CBD infused gummies

Cons:

What I Like About Royal CBD:

I remember receiving a press release from Royal CBD shortly before their launch, so I couldn’t help but try their products — as I do with any new brand that grabs my attention.

I’m a visualizer, so I was instantly bought with the minimalistic design of their products. Of course, I did some solid research to not rely solely on my gut, and it turned out this company has an unparalleled level of transparency.

They explain everything about how they source their hemp and what extraction they use for their CBD oil. Not only that, but they were also able to prove it with the lab results. I ordered two bottles — the 1000mg (for me) and 500mg (for my two boys).

What I love about Royal CBD is that their full-spectrum oil does what it’s advertised to do — it brings relief. My children sleep better, they don’t get irritated so easily, and I can finally get them focused on their homework for longer than 3 minutes, which is a blessing for me.

Oh, and it doesn’t leave that botanical aftertaste on the tongue. I’m a fan of everything related to hemp, but my boys don’t share my enthusiasm to that extent. Thankfully, the MCT oil does a stellar job at masking the natural hemp flavor.

2. Gold Bee (Best Organic CBD Oil)

Pros:
  • Made from US-grown, organic hemp
  • Contains full-spectrum CBD
  • 1200 mg of CBD per bottle (40 mg/mL)
  • Extracted with supercritical CO2
  • Delicious Kiwi flavor
  • Sweetened with organic honey
  • Third-party tested for cannabinoid content and purity
Cons:
  • Only one concentration available
  • Limited flavor options
What I Like About Gold Bee CBD Oil for Kids

Gold Bee offers craft-quality CBD oils that are well suited for kids, both in their potency and ingredients. The company sources its CBD from organic hemp grown in Colorado, which is then gently extracted using pressurized CO2. Gold Bee’s farming and processing practices yield pure CBD extracts that maintain consistent potency throughout all batches.

The CBD oil contains full-spectrum CBD, meaning there are other cannabinoids and terpenes to support the health benefits of CBD. These compounds contribute to the much-desired entourage effect. As a result, your kid needs less oil than they would if you gave them isolated CBD, making this product very affordable compared to competitor brands.

Even though Gold Bee only carries 2 potencies, 1200mg, and 2400mg, but their oils have proven to be much more effective than other brands. So if you are giving your child GB’s 1200mg CBD Oil, you should start with a quarter dropper, around 10mg of CBD.

I especially like Gold Bee because its product contains only organic ingredients, including the honey in the CBD oil and the cane sugar in the gummies. The brand is a safe pick for health-conscious parents.

3. Hemp Bombs

Pros:

  • Sourced from 100% certified organic hemp from Europe
  • Extracted with CO2
  • THC-free
  • Lab-tested for purity and potency
  • Highly versatile — you can use it as is or add it to food and drinks
  • Available in 5 potencies
  • Less expensive than full-spectrum CBD oil

Cons:

  • Lacks the entourage effect from other cannabinoids
  • Your children usually won’t need anything stronger than the 300mg bottle

What I Like About HempBombs CBD:

HempBombs specializes in making 99% pure CBD products. These isolates are available as tinctures, capsules, vape oils, or gummies.

I know that some parents — especially those new to cannabis — tend to freak out about any THC in hemp products they give to their kids, so if you’re one of those parents, isolates might be a good starting point. Your child may be allergic to some plant compounds; CBD isolate might be the only option here.

Isolates are highly versatile. Given this, if your pumpkin hates the taste of natural CBD oil, the isolate should do the trick as it’s odorless and flavorless. Because of that, you can also mix CBD with foods and drinks to smuggle some CBD into your kid’s favorite muffins or a fruit salad dressing.

Remember that CBD isolate is purged from any cannabinoids other than CBD, so there’s no entourage effect. But as I said, with parents using isolate-based products, the potency of CBD is likely more important than the whole-plant synergy.

4. CBDistillery

Pros:

  • Sourced from non-GMO, pesticide-free hemp
  • Extracted with CO2
  • Available as full-spectrum CBD or pure CBD oil (broad-spectrum, zero THC)
  • Lab-tested for purity levels and consistency in potency
  • Available in 5 different potency options
  • Very affordable

Cons:

  • Only available in the natural flavor
  • Not certified organic

What I Like About CBDistillery:

A veteran to the scene, CBDistillery never fails to deliver the highest quality and safety standards — both for adults and children.

Their oil is sold in five different potencies, from 250mg to 5000mg of full-spectrum or broad-spectrum (THC-free) extract. The 250mg CBD oil (my recommended potency for most kids) costs as little as $20, so it’s a perfect product for parents shopping for CBD on the budget.

I love the fact that you can also get a THC-free version of this oil but still enjoy the benefits of the other cannabinoids that have been preserved during extraction. I must admit it’s not as effective as Royal CBD, but it’s still a decent product. And for many young moms, this can be a golden mean between full-spectrum CBD oil and CBD isolate.

Using CBD With Children 101

I receive lots of questions from parents who would like to try CBD oil for their kids, but there’s so much confusion on the Internet that they get even more confused in the end.

So, my fellow moms, I’ve selected the 4 most frequently asked questions about CBD oil for kids, and I’m going to explain everything in the simplest way possible.

Is CBD Oil for Kids the Same as CBD Oil for Adults?

Yes, it’s precisely the same product. Companies don’t distinguish between CBD oil for kids or adults.

However, because children weigh less than adults, I suggest that you operate on lower potencies. Kids usually need lower amounts of CBD to feel the difference.

Besides, with a low-potency CBD oil (e.g., 250mg CBD per bottle), it’s easier to gauge the dosage in the dropper because you can use a few drops instead of having to measure out, say, one-tenth of the syringe for accurate dosing.

What Are the Benefits of CBD Oil for Children?

CBD is a highly versatile supplement that has a special relationship with our endocannabinoid system.

If you’re giving CBD oil to your kid for general supplementation purposes, you can expect the following benefits:

  • Improved focus
  • Higher alertness throughout the day
  • Better quality of sleep

On a practical note, CBD is easy to use, has a long shelf-life, and you can administer it to your child in many different ways.

What’s the Best Way to Use CBD With Children?

It goes without saying that your kids won’t be vaping CBD oil or dabbing CBD concentrates because first, they’re too potent, and second — the very consumption method is out of the question for children.

Most parents choose the sublingual method, which involves placing a few CBD oil drops beneath the kid’s tongue. Once there, they need to hold it for about 30–60 seconds until the oil gets absorbed into the bloodstream, then swallow.

It may happen that your tot isn’t a fan of CBD oil’s distinct taste and will turn its head away each time you try to administer it sublingually.

If that’s your story, I recommend CBD gummies. Each gummy comes with a fixed dose of CBD — you can skip that nasty dropper part — and they are sold in many delicious flavors.

I don’t need to tell you how much children love gummies, so this form of cannabidiol is a great way to give your little one the best of both worlds.

CBD Oil Dosage Guidelines for Kids

The optimal dosage for any given CBD user — including children — depends on their weight, metabolism, unique body chemistry, and desired effects.

For the pediatric population of CBD users, experts suggest starting with 0.5mg of CBD per pound and taking this dose three times a day.

Starting low and slow allows you to adjust the dosage to how your child reacts to CBD without causing any side effects (e.g., dry mouth or lightheadedness).

Quick Reference Chart for Children’s Dosages:
Weight (lbs) Low Strength Medium Strength
30 lbs (13 kg) 2.6 mg 7.8 mg
40 lbs (18 kg) 3.6 mg 10.8 mg
50 lbs (23 kg) 4.6 mg 13.8 mg
75 lbs (34 kg) 6.4 mg 19.0 mg
100 lbs (45 kg) 7.5 mg 22.5 mg

Final Thoughts on CBD Oils for Kids

CBD oil is an excellent tool for enhancing the quality of one’s life, not only for adults but also for children. Because of the non-psychoactive nature of CBD, this compound is doesn’t impact their mental development and comes with only a few mild side effects, such as dry mouth or dizziness when consumed in larger amounts.

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I hope my guide has helped you understand what CBD oil is and how it can help your kid live a better life. Now you can make a well-informed decision and buy a high-quality product that will benefit the whole family.

References:

  1. Murillo-Rodríguez, E., Sarro-Ramírez, A., Sánchez, D., Mijangos-Moreno, S., Tejeda-Padrón, A., Poot-Aké, A., … Arias-Carrión, O. (2014). Potential effects of cannabidiol as a wake-promoting agent. Current Neuropharmacology, 12(3), 269–272.
  2. Russo, E.B., Burnet, A., Hall, B., Parker, K.K. (2005). Agonistic properties of cannabidiol at 5-HT1a receptors
  3. Leweke, F. M., Piomelli, D., Pahlisch, F., Muhl, D., Gerth, C. W., Hoyer, C., … Koethe, D. (2012). Cannabidiol enhances anandamide signaling and alleviates psychotic symptoms of schizophrenia. Translational Psychiatry, 2(3), e94.
  4. Beale, C., Boyd, S. J., Chye, Y., Suo, C., Schira, M., Galettis, P., … Solowij, N. (2018). Prolonged Cannabidiol Treatment Effects on Hippocampal Subfield Volumes in Current Cannabis Users. Cannabis and cannabinoid research, 3(1), 94–107.
  5. Bar-Lev Schleider, L., Mechoulam, R., Saban, N., Meiri, G., & Novack, V. (2019). Real life Experience of Medical Cannabis Treatment in Autism: Analysis of Safety and Efficacy. Scientific reports, 9(1), 200.
Nina Julia

Nina created CFAH.org following the birth of her second child. She was a science and math teacher for 6 years prior to becoming a parent — teaching in schools in White Plains, New York and later in Paterson, New Jersey.

The protocol for the Cannabidiol in children with refractory epileptic encephalopathy (CARE-E) study: a phase 1 dosage escalation study

Initial studies suggest pharmaceutical grade cannabidiol (CBD) can reduce the frequency of convulsive seizures and lead to improvements in quality of life in children affected by epileptic encephalopathies. With limited access to pharmaceutical CBD, Cannabis extracts in oil are becoming increasingly available. Physicians show reluctance to recommend Cannabis extracts given the lack of high quality safety data especially regarding the potential for harm caused by other cannabinoids, such as Δ 9 -tetrahydrocannabinol (Δ 9 -THC). The primary aims of the study presented in this protocol are (i) To determine whether CBD enriched Cannabis extract is safe and well-tolerated for pediatric patients with refractory epilepsy, (ii) To monitor the effects of CBD-enriched Cannabis extract on the frequency and duration of seizure types and on quality of life.

Methods

Twenty-eight children with treatment resistant epileptic encephalopathy ranging in age from 1 to 10 years will be recruited in four Canadian cities into an open-label, dose-escalation phase 1 trial. The primary objectives for the study are (i) To determine if the CBD-enriched Cannabis herbal extract is safe and well-tolerated for pediatric patients with treatment resistant epileptic encephalopathy and (ii) To determine the effect of CBD-enriched Cannabis herbal extract on the frequency and duration of seizures. Secondary objectives include (i) To determine if CBD-enriched Cannabis herbal extracts alter steady-state levels of co-administered anticonvulsant medications. (ii) To assess the relation between dose escalation and quality of life measures, (iii) To determine the relation between dose escalation and steady state trough levels of bioactive cannabinoids. (iv) To determine the relation between dose escalation and incidence of adverse effects.

Discussion

This paper describes the study design of a phase 1 trial of CBD-enriched Cannabis herbal extract in children with treatment-resistant epileptic encephalopathy. This study will provide the first high quality analysis of safety of CBD-enriched Cannabis herbal extract in pediatric patients in relation to dosage and pharmacokinetics of the active cannabinoids.

Trial registration

http://clinicaltrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2016 Dec 16. Identifier NCT03024827, Cannabidiol in Children with Refractory Epileptic Encephalopathy: CARE-E; 2017 Jan 19 [cited 2017 Oct]; Available from: http://clinicaltrials.gov/ct2/show/NCT03024827

Background

The epileptic encephalopathies are a group of childhood-onset seizure disorders characterized by frequent seizures and markedly abnormal EEG patterns associated with progressive disturbance of cerebral function that manifests as developmental stagnation or regression. These epilepsies are often resistant to conventional medical treatment regimens and children with these conditions invariably experience neurological and cognitive impairments that severely impair their quality of life (QoL) [1].

In 2013 Porter and Jacobson reported the results of a 24-point survey they posted on a Facebook-group composed of parents using CBD-enriched Cannabis products to treat their children with refractory epilepsy. Of the 20 respondents, 84% reported the CBD-enriched Cannabis products resulted in a decrease in seizure frequency in their children and over half of their children either became seizure-free or had a greater than 80% reduction in their seizure frequency. Just as importantly, most parents reported an improvement in QoL indices such as alertness, sleep, and mood [2]. Since that time several open-label and randomized double-blind trials of CBD-based treatments in children with epileptic encephalopathy including Dravet Syndrome and Lennox Gastaut syndrome have been reported [3,4,5,6]. These studies found a reduced frequency of convulsive seizures and mild adverse events of somnolence and elevated liver-enzyme activities. Unfortunately, there was considerable variation in the dosage and types of CBD formulation used; three studies using a purified CBD product (Epidiolex) and one using a whole plant Cannabis herbal extract. The considerable variation in CBD dosage and lack of pharmacokinetic data resulted in no guidance on appropriate dosage regimens in this pediatric patient population.

CBD can be derived from pure pharmaceutical preparations or in extracts of Cannabis sativa or Cannabis indica [7]. The composition of Cannabis extracts can vary dramatically due to differences in cultivars, growing conditions, and extraction and decarboxylation processes. The lack of standardization or quality assurance in the preparation and dose administration of these products severely limits the scientific study of herbal preparations of Cannabis. The recent availability of commercial Cannabis extracts from a licensed medical marijuana producer that uses good manufacturing processes (GMP) with assayed cannabinoid composition assures patient safety and reliable dosing and enables scientific evaluation [8, 9]. We propose to conduct an open-label dose escalation study of CBD-enriched Cannabis herbal extract in pediatric patients with treatment resistant epileptic encephalopathy.

Methods/Design

Objectives

The primary objectives of the CARE-E study are:

To determine if a CBD-enriched Cannabis herbal extract is safe and well-tolerated for pediatric patients with treatment resistant epileptic encephalopathy.

To monitor the effects of a CBD-enriched Cannabis herbal extract on the frequency and duration of specific seizure types.

Secondary Objectives

To determine whether CBD-enriched Cannabis herbal extract will alter steady-state levels of co-administered anticonvulsant medications.

To assess how treatment of pediatric patients with treatment refractory epileptic encephalopathy with CBD-enriched Cannabis herbal extract will affect the patient’s QoL.

To determine the relation between dose escalation and steady-state trough levels of bioactive cannabinoids.

To determine the relation between dose escalation and improvement in seizure frequency, QoL and incidence of adverse effects.

Study product

The study product is an oil-based extract of Cannabis sativa purchased from CanniMed® Therapeutics Incorporated (Saskatoon, Canada) named ‘CanniMed® Oil 1:20’ with 1 mg/mL of Δ 9 -THC and 20 mg/mL of CBD. CanniMed® operates under the Access to Cannabis for Medical Purposes Regulations governed by Health Canada [10] using GMP. The general process for harvest, ethanol extraction, decarboxylation, concentration and solution in olive oil is described by CanniMed® [11]. The concentrations of Δ 9 -THC and CBD in the product, and lack of mold, mycotoxins, and pesticides are confirmed by a third party laboratory as mandated by Health Canada. The product is purchased as 60 mL graduated amber oval bottles (PETE) that are sealed with child-proof caps, labeled according to local law and identified by the protocol number and dosage. The Research Pharmacy at each site will receive the study product from CanniMed® for subsequent distribution to their site’s participants. As an oil-based suspension the product will be taken orally or by gastrostomy tube and the volume varies according to the weight of the participant. A single lot number of product was provided by CanniMed® for this study to ensure consistency of dosing. The product was purchased from CanniMed® at cost and this research remained independent of the company by securing all funding through external research grants.

Study population

The study will recruit participants between the ages of 1–10 years with an epileptic encephalopathy resistant to standard medical treatment. The study will aim to enroll 28 children from four Canadian cities (anticipated seven participants per site).

Study design

The CARE-E trial is a phase 1, open-label, dose-escalation study consisting of 4 separate phases: recruitment, baseline, treatment, and weaning. The recruitment phase involves the selection of eligible participants using pre-established exclusion and inclusion criteria (described below). The baseline phase establishes baseline values for each experimental measurement prior to treatment with the study product. During the treatment phase, caregivers of participants administer dosages of the CBD-enriched Cannabis herbal extract twice daily to their children escalating at fixed one-month intervals over the course of four-months. Upon completion of the treatment phase, participants will enter the weaning phase and caregivers will slowly taper the participants off of the CBD-enriched Cannabis herbal extract using a one-month weaning schedule.

During the study, caregivers will monitor the participants for any potential side effects and will use a study diary to record their child’s seizure activity by tracking seizure frequency and duration, and any use of rescue medications to abort prolonged seizures. The participant’s condition as well as drug levels and biomarkers of toxicity will be monitored on a monthly basis. Testing will include blood and urine analysis, QoL assessments, neurological and general pediatric assessments, and an electroencephalogram (EEG) recorded for 2 h or until sleep is obtained (Fig. 1).

A flow chart of participant enrollment, treatment with CBD-Enriched Cannabis herbal extract, monitoring and weaning

Recruitment Phase: Prospective participants will be directly identified and recruited through the caregivers by study physicians at each study site. Any potential participants’ caregiver will be contacted by the study physician or pediatric neurology nurse either in-person at the study physician’s clinic or by telephone. Prospective caregivers of participants will be asked if they are interested in having their child participate in the study. If the response is positive, a copy of the study brochure and consent form will be provided to them. Caregivers of prospective participants will be asked to attend a recruitment visit after they agree to participate in the study and provide informed consent. During the recruitment visit, the participant will be screened for eligibility based on specific inclusion and exclusion criteria. If the participant qualifies for the study, the participants’ caregivers will be instructed on use the study diary.

Inclusion and exclusion criteria: Participation in this study is inherent on meeting the following inclusion criteria: (1) Participants must be between the ages of 1 and 10 years of age with treatment-resistant epileptic encephalopathy including: Infantile Spasms, Continuous Spike Wave in Sleep, Lennox Gastaut, Doose, Landau-Kleffner and Dravet Syndromes and Malignant Migrating Partial Seizures of Infancy. ‘Treatment-resistant’ will be in keeping with the International League Against Epilepsy (ILAE) definition of failing two appropriate anticonvulsant medications at therapeutic doses. (2) Participants must experience a minimum of at least one major seizure per week or four major seizures per month. For the purposes of this study, major seizures will be motor seizures including: atonic, tonic, clonic, tonic-clonic, major myoclonic, myoclonic astatic seizures and epileptic spasms. (3) Participants must be available to attend study assessments regularly and enter data into the seizure monitoring logs correctly. (4) Negative pregnancy test at screening for females who have reached menarche.

Subject Withdrawal Criteria: A participant may be withdrawn from the study if: (1) The study drug is causing intolerable side effects or a worsening in the participant’s seizures; (2) The caregiver fails to give the study drug to the participant as prescribed; (3) The caregiver does not bring the participant to appointments; (4) The study at a particular site is cancelled by the principal investigator, a site investigator or the institutional sponsor for administrative or other reasons. Whenever possible, the participant withdrawn from the study will continue to receive a dosage schedule that gradually weans the participant off the study drug over a one-month period. However, if the site investigator deems it medically necessary for the participants’ safety, the participant could be weaned off the study drug faster. All participants that complete the study will be asked to return for an end of study visit (Visit 7). All data collected about the participant during enrolment will be retained for analysis and the participant will not be replaced.

Baseline Phase: Following the recruitment visit, participants will be sent home for one month with no change to their current anticonvulsant therapy, ketogenic diet, or Vagal Nerve Stimulator settings. Caregivers will be asked to track their child’s seizure frequency, duration, and use of rescue medication during this month. Rescue medications allowed for home-use include: Ativan (0.1–0.2 mg/kg PRN intrabucally, sublingual or IV), Midazolam (0.1–0.2 mg/kg PRN intranasally, intrabucally or IV), or Diazepam (0.2–0.5 mg/kg PRN rectally or IV). Other rescue medications may be administered by paramedics (under physician guidance) or physicians as per hospital guidelines or the child’s individual guidelines for management of status epilepticus. At the end of this month, participants and their caregivers will be required to visit the study clinic for a series of baseline tests including: blood and urine analyses, quality of life and cognitive/developmental assessments, neurological and general pediatric assessment, and an EEG lasting 2 h or until the participant falls asleep. Data from the seizure diaries will be collected and a new diary will be provided for the following month.

Treatment phase: Initiation of therapy: Following baseline testing, caregivers of participants will receive a 33-day supply of the 1:20 Δ 9 -THC:CBD Cannabis herbal extract from the site research pharmacist at visit 2. Caregivers of participants will be instructed to administer the study product at a 1:20 Δ 9 -THC:CBD Cannabis herbal extract dose of 2–3 mg/kg/day divided into two doses (BID). Caregivers will be further instructed to monitor their child’s seizure activity as defined above. In addition, they will be asked to monitor their child for any potential side effects such as drowsiness, ataxia, nausea, vomiting, worsening seizures, etc.

Monthly follow-up: Caregivers will return to the clinic for the monthly testing as described above. Data from the study diaries will be copied for analysis. Following the completion of testing, parents will receive a new 33-day supply of the 1:20 THC:CBD Cannabis herbal extract from the research pharmacist. Parents will be instructed to administer the extract at increasing doses over the next 3 months; i.e. at 5–6 mg/kg/day divided BID at visit 3, 8–10 mg/kg/day divided BID at visit 4, and 10–12 mg/kg/day divided BID at visit 5. If the participant experiences significant side-effects at a certain dose, the subsequent CBD dose will be adjusted to the mid-point between their current dose and former dose. Parents will be instructed to continue tracking their child’s seizure activity and monitoring the child for potential side effects in the same manner as the initiation of therapy month.

Dosage of 1:20 Δ 9 -THC:CBD Cannabis herbal extract

Rationale for escalating dose of CBD to 10–12 mg/kg/day

As there is no available pediatric pharmacokinetic data for the cannabinoids including CBD and THC, the dosage regimen used in this study is extrapolated from CBD dosages previously described in the literature [2,3,4,5,6]. Consideration is made of the fact that the study product is derived from a whole plant extract that contains Δ 9 -THC among other potentially biologically active cannabinoids and terpines.

In Jacobson and Porter’s report, most children who had a positive response to CBD were taking a dose ranging from 8 to 14 mg/kg/day [2]. Devinsky and Thiele used a dose of 20 mg/kg/day in their participants randomized to receive study drug but this was a purified CBD product with negligible concentrations of Δ 9 -THC [5, 6]. Tzadok’s study participants received a CBD dose of either < 10 mg/kg/day or 10–20 mg/kg/day provided in the form a CBD-enriched Cannabis extract [4].

Regarding calculation of dosage and distribution of 1:20 Δ 9 -THC:CBD Cannabis herbal extract at each study visit

To ensure consistency between centers in the dosing regimen for their study participants, for each dosing increment for the participant, the mid-point value of the dosage range be chosen and the daily dosage be rounded to the nearest 10 mg CBD (0.5 ml of Cannabis Extract). This will also allow for greater ease and accuracy in administering the study drug to the participants by their caregivers. For example, a participant who weighs 25 kg at Visit 1 would be prescribed a daily dose of 60 mg CBD (2.4 mg/kg/day) to commence on Visit 2. The dosage for each visit would be calculated on the preceding visit to allow time for the site’s research pharmacy to order the study drug so it can be delivered on time by the producer.

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Drug distribution and accountability

In order to comply with Health Canada requirements for a clinical study involving a Cannabis product, care is taken to ensure accountability with regards to the amount of 1:20 Δ 9 -THC:CBD Cannabis herbal extract dispensed to- and utilized by- the study participant. Proper disposal of unused or excess Cannabis herbal extract must be ensured. For this reason, the Cannabis herbal extract will be distributed via the research pharmacies at each study site. This will allow for greater accountability with regards to the amount of Cannabis herbal extract dispensed to and used by the study participants. This will also prevent the possibility of Cannabis herbal extract being shipped to participants who have withdrawn from the study or fail to attend study visits. As a total supply for 33 days will be allotted to each participant to allow some flexibility in scheduling study visits, Health Canada Section 56A Exemptions had to be obtained for the research pharmacy at each study site. Upon receipt of the 1:20 Δ 9 -THC:CBD Cannabis herbal extract by the research pharmacy, the quantity received will be recorded in a drug receipt record and the 1:20 Δ 9 -THC:CBD Cannabis herbal extract will be stored in a locked drug cabinet at the research pharmacy until such time that it will be dispensed to the participant. Once dispensed by the research pharmacy to the participant, the amount dispensed as well as the date and time will be recorded in a drug dispensing log. When the study participant returns for their subsequent visit, they will return all empty bottles as well as any unused 1:20 Δ 9 -THC:CBD Cannabis herbal extract to the research pharmacy. The amount of 1:20 Δ 9 -THC:CBD Cannabis herbal extract returned will be recorded in the drug dispensing log and a calculation will be performed to ensure it matches the estimated amount that should have been returned based on the participant’s daily dose and the date of return. To help contain costs of performing this study, for visits 3–6, any unused 1:20 Δ 9 -THC:CBD Cannabis herbal extract will be re-dispensed to the study participant and calculated into the total amount dispensed. At visit 7, any unused 1:20 Δ 9 -THC:CBD Cannabis herbal extract will be recorded and stored along with the unused 1:20 Δ 9 -THC:CBD Cannabis herbal extract for all participants at that site to be destroyed as per the research pharmacy’s specific guidelines.

Weaning phase: Termination of treatment: At visit 6 (after completing 1 month of CBD at 10–12 mg/kg/day) participants will return to the clinic for a final series of tests which include: blood and urine analyses, quality of life and cognitive/developmental assessments, neurological and general pediatric assessments, and EEG. Participants will be provided with a one-month weaning schedule which incrementally decreases the dose of the 1:20 Δ 9 -THC:CBD Cannabis herbal extract administered (CBD at 8–9 mg/kg/day for 1 week then 5–6 mg/kg/day for 1 week then 2–3 mg/kg/day for 1 week prior to discontinuing the study product).

Final Assessment: Participants will return to the clinic upon completion of the one-month weaning period. Caregivers will provide observations of any side-effects noted during the weaning period and will complete a final quality of life questionnaire. Data from the seizure monitoring diaries will be collected and caregivers will be asked to return any leftover study drug.

Experimental measurements

Bioactive cannabinoid plasma concentrations

A secondary study objective is to determine the relationship between dose escalation and steady state trough concentrations of bioactive cannabinoids, and if possible, relate these levels with therapeutic and adverse effects. To achieve this objective a liquid chromatography-mass spectrometry (LC-MS/MS) method was validated in accordance with the United States FDA guidelines [12, 13]. Blood collected into lithium heparin Barricor vacutainers ® (BD Canada, Mississauga, ON) at each visit will be centrifuged (10 min at 1500 rpm), the plasma aliquoted into clearly labeled microcentrifuge tubes, and placed at − 80 °C until analysis. Plasma concentrations of THC, CBD and THC-OH (11-hydroxy-THC) in participant plasma samples will be determined by LC-MS/MS analysis. Briefly, stock solutions (1 mg mL − 1 ) of cannabinoids and their respective stable isotope labeled internal standards (Cerilliant Corp., Round Rock, TX) will be prepared in methanol and stored at − 20 °C. Working solutions will be prepared by serial dilution of the stock solution in blank human plasma to produce appropriate standard calibration curves. Acceptance criteria for each analytical run will be based on low, medium, and high concentration quality control (QC) standards. Calibration and QC samples will be prepared on each day of sample analysis. A linear least-squares regression analysis using 1/X 2 as weighting factor will be conducted to determine the linearity of the calibration curve. Plasma sample extraction involves the addition of 10 μL of the internal standard working solution and 600 μL of cold acetonitrile to 200 μL plasma, followed by vortex-mixing and centrifugation at 20,000 g for 10 min at 4 °C. 700 μL of supernatant is dried under filtered air for 15 min at 37 °C. Samples are reconstituted using 200 μL mobile phase. Supernatant will be transferred to HPLC inserts and 5 μL injected onto a Zorbax Eclipse XDB-C18 narrow bore 2.1 × 12.5 mm 5 μm guard column and Zorbax Eclipse XDB-C8 narrow bore 2.1 × 12.5 mm 5 μm guard column with column temperature maintained at 30 °C. The cannabinoids are separated using an Agilent series 1290 binary pump (Agilent Technologies, Mississauga, ON, Canada) with an online degasser and auto sampler set at 4° and a mobile phase of 80% methanol and 20% Solution B (0.1 mM ammonium formate) at a flow rate of 250 μL/min. Injections will occur at 13.5 min intervals and will include linear gradients to 90% methanol 10% Solution B at 3.5 min to 10 min and return to 80% methanol: 20% Solution B from 10 min to 10.5 min.

The cannabinoids will be detected with an ABSciex 6500 QTRAP mass spectrometer (AB Sciex, Concord, ON, Canada) in positive ion mode. Multiple reaction monitoring (MRM) will be used to quantify the cannabinoids and the peak areas will be summed through use of MultiQuant 3.0.1 Software. The ratio of peak areas of the cannabinoids to their respective internal standards will be plotted against the nominal concentrations to construct the calibration curve and the concentrations of the cannabinoids determined by interpolation.

Complete blood counts and clinical chemistry

At each visit participants will have laboratory assessment of blood components to evaluate hepatic, renal, or hematopoietic toxicity performed at their local hospital laboratory. The tests performed include: a complete blood cell count panel with automated three or five part cell differential, electrolytes, glucose, creatinine, urea, alanine transaminase, aspartate transaminase, albumin, gamma glutamyl transferase and lipase. Adverse events from each participant will be assessed as laboratory results that exceed the local laboratory age-specific reference intervals. If participants are on a ketogenic diet during the study, then urine ketone testing will be performed to assess the consistency of the ketosis at each visit.

Trough levels of anticonvulsants

Participants will remain on pre-existing anticonvulsant medications throughout the cannabis oil study period. Serum specimens will be collected from participants at each visit and trough levels of serum anticonvulsant medications will be determined by LC-MS/MS by the Roy Romano Provincial Laboratory Regina, SK, Canada. Serum specimens were collected and stored at − 20 °C prior to analysis. Adverse events will be counted if participants require a change in anticonvulsant medication during the trial either to maintain trough levels in the therapeutic range.

Quality of life assessment

The instrument we have chosen is the Quality of Life in Childhood Epilepsy (QOLCE-55) [14]. The QOLCE is a parent/proxy-completed measure of health-related quality of life specifically developed for children with epilepsy. It has several subsections containing multiple items, as well as a series of global ratings. The original tool was designed for individuals between 4 and 18 years of age which is one of the broadest age ranges for a tool of this kind. The tool allows for the rater to indicate that an item is not applicable if its content is above the age or developmental level of the child being rated. This makes the QOLCE potentially robust in the face of issues such as lower age and intellectual disability.

The QOLCE-55 shows good internal consistency and criterion-related validity as well as adequate to good test-retest reliability, depending on the subtest or item involved [14,15,16]. Areas covered include physical features (including physical limitations and fatigue), well-being (including depression, anxiety, helplessness and self-esteem), cognition (including attention, memory, language and general cognition), social engagement (including interactions, activities and stigma), and behavior. The QOLCE has also been shown to be sensitive to seizure activity and other clinical and psychosocial variables associated with epilepsy [14] and to benefits from treatments such as surgery [17]. Finally, the QOLCE has been used in the study of epileptic conditions with associated cognitive delays and Intellectual Disability and has already shown its utility in samples with Intellectual Disabilities [18]. While the QOLCE-55 was not exclusively positive in the wording of its items, most items were positively stated, making for less distress on the side of those completing the measure [19].

Ratings on the QOLCE are made on a 5-point scale with 1 titled “very often” and 5 titled “never.” Reversed items are recoded when scoring such that higher scores mean more positive outcomes. These scores are then recoded as follows: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100. The mean for each of the subscales is then found by adding these values together and dividing by the number of items not marked Not Appropriate. The total score for the scale is the unweighted mean of the four subscales.

As well, for the purposes of our study we added 13 additional items based on reports from parents. Additional items covered sleep (including being drowsy), verbal and nonverbal communication, use of books, awareness of surroundings, interpersonal interactions with children and adults, and irritability. These additional items are scored as other QOLCE items and are summed into their own total score as well as being looked at individually.

Seizure monitoring

Seizure monitoring will be used to determine how treatment with the study compound affects seizure frequency duration. Caregivers will be asked to track the frequency and duration of their child’s three most frequent types of seizures on a daily basis using a study diary. In order for the study to remain consistent, the caregivers will track the same three types of seizures throughout the study. Seizures that occur in a cluster will be counted as one seizure although the duration of the cluster and number of seizures per cluster will be recorded. Although dialeptic seizures are not included as part of the inclusion criteria for the study, caregivers will be encouraged to record the frequency of dialeptic seizures if their child experienced them frequently.

Use of rescue medication

Caregivers will be asked to track their child’s use of rescue medication. This will determine whether treatment with the study compound has any influence on use of rescue medication. Caregivers will record the medication used, the dosage used, and the number of times it was administered.

Sample size determination

As CARE-E is a phase I dose escalation safety and tolerability study designed to find the most appropriate dose of CBD in a pediatric population it was felt that power analysis was not required to calculate sample size. The sample size of 28 participants each receiving 4 separate dosage escalations is within usual guidelines for standard phase I clinical trial designs. In this multi-site dose escalation study, we chose to escalate within the same participant with 7 participants at each site because the low pediatric population incidence of epileptic encephalopathy (the inclusion criterion), precluded ability to escalate in cohorts of 6, where a new cohort of six would be administered the next dosing level [20, 21]. Any patient exhibiting a dose limiting toxicity will not receive the next dose escalation.

Data analysis

Study data will be collected and managed using REDCap electronic data capture tools hosted at the University of Saskatchewan [22]. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources.

Statistical analysis

All data will be descriptively analyzed using means, standard deviations, frequencies (where appropriate), and 95% confidence intervals. The sample size of 28 participants is sufficient for an initial phase 1 safety and tolerability study, but is too small for precise estimation of steady state levels of biologically active cannabinoids at each dose and for definitive assessments of efficacy. Trends will be examined and a medical statistician will assist with statistical and trend analysis of the data. Complete, specific details of the statistical analysis will be described and fully documented in the Statistical Analysis Plan (SAP) after completion of data collection.

Study funding:

Given the potential controversy surrounding the study of Cannabis products in children, CARE-E was funded entirely through external funding in order to minimize the potential for perceived bias in our study results. Funding was obtained through research grants from the Jim Pattison Children’s Hospital Foundation (formerly the Children’s Hospital Foundation of Saskatchewan), the Saskatchewan Health Research Foundation and the Savoy Foundation as well as a donation from the Durwood Seafoot Estate (administered through the Jim Pattison Children’s Hospital Foundation).

Discussion

Children with epileptic encephalopathies resistant to standard therapy are at considerable risk for long-term neurocognitive impairment and poor quality of life. CBD-enriched Cannabis based therapies have been shown in several studies to provide a reduction in seizure frequencies and improvements in sleep patterns, mood, and alertness. Such favorable reports in the medical literature and social media have prompted parents who are desperate to help their children to combine Cannabis products with current medical treatments in children with refractory epilepsy. However, the encouraging publicity surrounding medical marijuana is not accompanied by strong scientific and rigorous investigation. This is particularly true for this vulnerable pediatric population.

As a Phase I dose escalation study, the CARE-E study is primarily designed to assess safety of a high CBD, low ∆ 9 -THC Cannabis oil preparation. However, it is anticipated that the study can begin to address other major issues associated with Cannabis use in pediatric epileptic encephalopathies, namely the lack of an accepted dosage regimen, the relationship between steady state plasma concentrations and efficacy or adverse effects, its efficacy to reduce seizure frequency and improve quality of life, and potential drug-drug interactions with standard medical treatments for pediatric epilepsy. Successful implementation of the CARE-E study will lay foundation for a larger Phase II efficacy trial of a high CBD, low ∆ 9 -THC Cannabis oil product. Such studies are imperative to alleviate the lack of clinical information on medical Cannabis in children with refractory seizures and give practitioners confidence to prescribe Cannabis-derived products to their patients.

While CARE-E has a small sample size and open label design, there are several strengths that differentiate CARE-E from other studies. The multicenter design allows for a wider range of study participants and prevents intrinsic bias in interpretation of study results. The recording of EEG activity in participants allows for an objective measurement of efficacy of the Cannabis herbal extract in relation to dosage and steady state pharmacokinetics. Procurement of external funding to perform this study also prevents perception of bias in the collection and reporting of study results.

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