Characterizing the Use of Nabiximols (∆9-Tetrahydrocannabinol–Cannabidiol) Buccal Spray in Pediatric Patients
Bibliographic record
Abstract
Background: Nabiximols is a commercially available cannabinoid buccal spray containing 2.7 mg ∆9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD) per spray. It is approved by Health Canada for adults with cancer pain or spasticity/neuropathic pain related to multiple sclerosis. Despite a lack of published studies regarding the use of nabiximols in children, it is being used in clinical practice for indications of pain, nausea/vomiting, and spasticity. Objective: To describe the use of nabiximols in children. Methods: This retrospective single-cohort study involved hospitalized pediatric patients who received at least 1 dose of nabiximols between January 2005 and August 2018. Descriptive statistical analyses were performed. Results: A total of 34 patients were included. The median age was 14 (range 0.6–18) years, and 11 patients (32%) were admitted under the oncology service. The median dose of nabiximols was 1.9 (range 0.3–10.8) sprays per day, and the median duration was 3.8 (range 1–213) days. Nabiximols was most commonly used to treat pain and nausea/vomiting and was most frequently prescribed by pain specialists. Perceived effectiveness was documented in 17 (50%) of the cases, with variable results being reported. The most commonly reported adverse effects were drowsiness and tachycardia (3/34, 9%, for each). Conclusion: In this study, nabiximols was prescribed for children in all age groups, for a variety of conditions, but most commonly for pain and nausea/vomiting. Further study, in the form of a large, prospective randomized controlled trial with clearly defined efficacy and safety end points for nausea/vomiting and/or pain, is needed to determine whether nabiximols is effective and safe in children. RÉSUMÉ Contexte : Le nabiximols est un vaporisateur buccal cannabinoïde disponible dans le commerce qui contient 2,7 mg de ∆9-tetrahydrocannabinol [THC] et 2,5 mg de cannabidiol [CBD] par vaporisation. Il est approuvé par Santé Canada pour les adultes souffrant de douleur cancéreuse ou de spasticité/douleur neuropathique liée à la sclérose en plaques. Malgré le manque d’études publiées concernant l’utilisation du nabiximols chez les enfants, il est utilisé en pratique clinique pour des indications de douleur, de nausées/vomissements et de spasticité. Objectif : Décrire l’utilisation du nabiximols chez les enfants. Méthodes : Cette étude rétrospective à cohorte unique comprenait des patients pédiatriques hospitalisés ayant reçu au moins 1 dose de nabiximols entre janvier 2005 et août 2018. Des analyses statistiques descriptives ont été réalisées. Résultats : Au total, 34 patients ont été inclus. L’âge médian était de 14 ans [intervalle de 0,6 à 18 ans] et 11 enfants (32 %) étaient des patients en oncologie. La dose médiane de nabiximols était de 1,9 [intervalle de 0,3 à 10,8] vaporisation par jour et la durée médiane était de 3,8 [intervalle de 1 à 213] jours. Le nabiximols était le plus couramment utilisé pour traiter la douleur et les nausées/vomissements et était le plus souvent prescrit par des spécialistes de la douleur. L’efficacité perçue a été documentée dans 17 (50 %) des cas, avec des résultats variables rapportés. Les effets indésirables le plus fréquemment rapportés étaient la somnolence et la tachycardie (3/34, 9 % chacun). Conclusion : Dans cette étude, le nabiximols a été prescrit à des enfants de toutes les tranches d’âge, pour diverses pathologies, mais le plus souvent pour des douleurs et des nausées/vomissements. Une étude plus approfondie, sous la forme d’un vaste essai contrôlé randomisé prospectif avec des paramètres d’efficacité et d’innocuité clairement définis pour les nausées/vomissements et/ou la douleur, est nécessaire pour déterminer si le nabiximols est efficace et sûr chez les enfants.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".