A Multicenter Dose-escalation Study of the Analgesic and Adverse Effects of an Oral Cannabis Extract (Cannador) for Postoperative Pain Management

Anita Holdcroft, Mervyn Maze, Caroline Doré, Susan Tebbs, Simon Thompson
2006 Anesthesiology  
could provide pain relief with minimal side effects for postoperative pain. Methods: Patients (aged 18 -75 yr) were recruited and consented before surgery if patient-controlled analgesia was planned for provision of postoperative pain relief. Each patient received a single dose of 5, 10, or 15 mg Cannador if he or she had at least moderate pain after stopping patient-controlled analgesia. Starting with 5 mg, dose escalation was based on the number of patients requesting rescue analgesia and
more » ... rse effects. Pain relief, pain intensity, and side effects were recorded over 6 h and analyzed using tests for trend with dose. Results: Rescue analgesia was requested by all 11 patients (100%) receiving 5 mg, 15 of 30 patient (50%) receiving 10 mg, and 6 of 24 patients (25%) receiving 15 mg Cannador (log rank test for trend in time to rescue analgesia with dose P < 0.001). There were also significant trends across the escalating dose groups for decreasing pain intensity at rest (P ‫؍‬ 0.01), increas-ing sedation (P ‫؍‬ 0.03), and more adverse events (P ‫؍‬ 0.002). The number needed to treat to prevent one rescue analgesia request for the 10-mg and 15-mg doses, relative to 5 mg, were 2.0 (95% confidence interval, 1.5-3.1) and 1.3 (95% confidence interval, 1.1-1.7) , respectively. The study was terminated because of a serious vasovagal adverse event in a patient receiving 15 mg. Conclusion: These significant dose-related improvements in rescue analgesia requirements in the 10 mg and 15 mg groups provide a number needed to treat that is equivalent to many routinely used analgesics without frequent adverse effects.
doi:10.1097/00000542-200605000-00021 pmid:16645457 fatcat:b35ym2bbtrciphc4ty2ddjqcqe