Efficacy and safety of paediatric medicinal cannabis use: A scoping review
Cannabidiol; Cannabis; Drug-resistant epilepsy; Medicinal marijuana; Scoping review; Tetrahydrocannabinoid; Medicinal Cannabis
INTRODUCTION: The use of medicinal cannabis in the paediatric age group is increasing despite the lack of evidence for its efficacy or safety. OBJECTIVE: To map the available evidence on the efficacy and safety of medicinal cannabis in children and adolescents. METHODS: We conducted a scoping review and searched six electronic databases and grey literature. A study was eligible for inclusion when it investigated the efficacy or safety of medicinal cannabis for any condition, more than half of the participants were 0 to 18 years old, and had any study design except single case reports. RESULTS: We included 36 studies in our final analysis, 32 of which investigated the efficacy or safety of cannabis in treatment-resistant epilepsy. The remaining 4 studies examined patients with cancer, dysautonomia, Epidermolysis Bullosa, and motor disorders. CONCLUSIONS: There is a lack of evidence on the efficacy and safety of medicinal cannabis in most paediatric conditions.
Pawliuk C; Chau B; Rassekh SR; McKellar T; Siden H
Paediatrics and Child Health
2021
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
<a href="http://doi.org/10.1093/pch/pxaa031" target="_blank" rel="noreferrer noopener">10.1093/pch/pxaa031</a>
Safety and pharmacokinetics of medical cannabis preparation in a monocentric series of young patients with drug resistant epilepsy
Adolescent; Adult; Child; Female; Humans; Male; Child Preschool; Dose-Response Relationship Drug; Young Adult; Prospective Studies; Cannabidiol (CBD); Childhood; Delta-9-tetrahydrocannabinol (THC); Drug-resistant epilepsy; Medical cannabis galenic preparation; Drug Resistant Epilepsy/drug therapy; Medical Marijuana/administration & dosage/adverse effects/pharmacokinetics
OBJECTIVES: To evaluate safety and pharmacokinetic parameters (PK) of medical cannabis in add-on for children and young adults with drug-resistant epilepsy. DESIGN, SETTING: Ten patients (4 females, 6 males, age 2.5-23.2 years) were enrolled in a prospective open trial with a galenic preparation (decoction) of Italian cannabis (FM2, ratio THC:CBD = 3:5, range THC 5.2-7.2 %; CBD 8.2-11.1 %). Patients received the first dose in Hospital, progressively augmented by CBD dose titration (from 1 to 4 mg/kg/day). OUTCOME MEASURES: In order to assess safety, blood parameters, heart rates and electrocardiograms (ECGs) were evaluated before the enrollment and during the follow up. The PK study was performed measuring THC and CBD concentrations by UHPLC-MS/MS in plasma samples collected during the first administration and at each follow-up visit. RESULTS: Two out of ten patients stopped the treatment for adverse events (detected in 6/10: gastroenteric, sleep or behavioral disorders) and difficulties in drug supply. We observed minor ECG alterations in two patients and asymptomatic transient reductions of fibrinogen after 6 months of therapy. The PK study during follow-up revealed statistically significant correlations between THC-CBD blood concentrations and: volumes of decoction, FM2 and THC-CBD daily dosages. CONCLUSIONS: The present study, although with some limitations, shows a good safety profile of medical cannabis in children and young patients with drug-resistant epilepsy and encourages the possibility of further studies with oral cannabis-based drugs. The correlations between THC-CBD plasma concentrations and their administered dosages underline the need of a therapeutic drug monitoring for cannabinoids therapy.
Gherzi M; Milano G; Fucile C; Calevo MG; Mancardi MM; Nobili L; Astuni P; Marini V; Barco S; Cangemi G; Manfredini L; Mattioli F; De Grandis E
Complementary Therapies in Medicine
2020
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
<a href="http://doi.org/10.1016/j.ctim.2020.102402" target="_blank" rel="noreferrer noopener">10.1016/j.ctim.2020.102402</a>