Abstract
Purpose
Cannabinoids have been shown to have analgesic properties in animal studies, but a potential role for these drugs in acute pain management has not been established. It was hypothesized that nabilone, an oral cannabinoid synthetic tetrahydrocannabinol analogue, decreases morphine consumption, pain scores, nausea and vomiting following major surgery.
Methods
A double-blind, randomized, placebo-controlled, parallel-group pilot trial compared the effects of two different doses, 1 mg (n = 11) and 2 mg (n = 9) of nabilone, ketoprofen 50 mg (n = 11) or placebo (n = 10), given at eight-hour intervals for 24 hr. Outcomes included morphine consumption, pain scores and emesis after major surgery. Secondary outcomes included patient tolerability of the study medication.
Results
Forty-one patients (mean age 52 ± 2 yr) undergoing gynecologic (46%), orthopedic (44%), or other (10%) surgery were recruited. Cumulative 24-hr morphine consumption was not different between the four groups, but pain scores at rest and on movement were significantly higher in the 2 mg nabilone group compared to the other groups. There were no significant differences between groups with respect to episodes of nausea and vomiting, quality of sleep, sedation, euphoria, pruritus, or the number and severity of adverse events. No serious adverse event was recorded.
Conclusions
Contrary to the main hypothesis, high dose nabilone in the presence of morphine patient controlled analgesia is associated with an increase in pain scores in patients undergoing major surgery.
Résumé
Objectif
Les propriétés analgésiques des cannabinoïdes ont été démontrées chez des animaux, mais leur rôle possible sur le contrôle de la douleur aiguë n’a pas été établi. Notre hypothèse voulait que la nabilone, analogue synthétique oral du cannabinoïde tétrahydrocannabinol, diminue la consommation de morphine, les scores de douleur, les nausées et les vomissements à la suite d’une opération chirurgicale majeure.
Méthode
Dans une étude pilote de groupes parallèles, randomisée, à double insu et contrôlée contre placebo, les effets de deux doses de nabilone, 1 mg (n = 11) et 2 mg (n = 9), de 50 mg de kétoprofène (n = 11) ou d’un placebo (n = 10), administrés à 8 h d’intervalle pendant 24 h, ont été comparés. La consommation de morphine, les scores de douleur et les vomissements ont été notés après une chirurgie majeure. Les effets de la médication sur le patient étaient également étudiés.
Résultats
Quarante et un patients (moyenne d’âge de 52 ± 2 ans) subissant une intervention gynécologique (46 %), orthopédique (44 %) ou autre (10 %) ont été recrutés. La consommation cumulative de morphine sur 24 h était similaire dans les quatre groupes, mais les scores de douleur au repos et au mouvement ont été significativement plus élevés dans le groupe nabilone 2 mg. Aucune différence intergroupe significative n’est apparue quant aux épisodes de nausées et de vomissements, la qualité du sommeil, la sédation, l’euphorie, le prurit ou le nombre et la sévérité des événements indésirables. Aucun incident sérieux n’a été enregistré.
Conclusion
Contrairement à notre hypothèse, une forte dose de nabilone, en présence de morphine administrée comme analgésie auto-contrôlée, est associée à une hausse des scores de douleur chez les patients qui subissent une chirurgie majeure.
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Funding: This clinical trial was funded by a grant from the Canadian Institutes of Health Research (Grant # MCT-64678) and from Valeant Pharmaceuticals Inc. Dr. Beaulieu held a research salary grant from the Fonds de la recherche en santé du Québec and received start-up funding from the Research Centre of the CHUM.
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Beaulieu, P. Effects of nabilone, a synthetic cannabinoid, on postoperative pain. Can J Anesth 53, 769–775 (2006). https://doi.org/10.1007/BF03022793
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DOI: https://doi.org/10.1007/BF03022793