PDF(Pubmed)
Abstract：
Odontogenic pain can be debilitating, and nonopioid analgesic options are limited. This randomized placebo-controlled clinical trial aimed to assess the effectiveness and safety of cannabidiol (CBD) as an analgesic for patients with emergency acute dental pain. Sixty-one patients with moderate to severe toothache were randomized into 3 groups: CBD10 (CBD 10 mg/kg), CBD20 (CBD 20 mg/kg), and placebo. We administered a single dose of respective oral solution and monitored the subjects for 3 h. The primary outcome measure was the numerical pain differences using a visual analog scale (VAS) from baseline within and among the groups. Secondary outcome measures included ordinal pain intensity differences, the onset of significant pain relief, maximum pain relief, changes in bite force within and among the groups, psychoactive effects, mood changes, and other adverse events. Both CBD groups resulted in significant VAS pain reduction compared to their baseline and the placebo group, with a maximum median VAS pain reduction of 73% from baseline pain at the 180-min time point (P < 0.05). CBD20 experienced a faster onset of significant pain relief than CBD10 (15 versus 30 min after drug administration), and both groups reached maximum pain relief at 180-min. Number needed to treat was 3.1 for CBD10 and 2.4 for CBD20. Intragroup comparisons showed a significant increase in bite forces in both CBD groups (P < 0.05) but not in the placebo group (P > 0.05). CBD20 resulted in a significant difference in mean percent bite force change in the 90- and 180-min time points compared to the placebo group (P < 0.05). Compared to placebo, sedation, diarrhea, and abdominal pain were significantly associated with the CBD groups (P < 0.05). There were no other significant psychoactive or mood change effects. This randomized trial provides the first clinical evidence that oral CBD can be an effective and safe analgesic for dental pain.
摘要：
牙源性疼痛可能使人衰弱，和非阿片类镇痛药的选择是有限的。这项随机安慰剂对照临床试验旨在评估大麻二酚（CBD）作为紧急急性牙痛患者的镇痛药的有效性和安全性。61例中度至重度牙痛患者随机分为3组：CBD10（CBD10mg/kg），CBD20（CBD20mg/kg），和安慰剂。我们给予单剂量的各自口服溶液并监测受试者3小时。主要结果测量是使用视觉模拟量表(VAS)在组内和组间与基线的疼痛数值差异。次要结局指标包括顺序疼痛强度差异，显著缓解疼痛的开始，最大程度地缓解疼痛，组内和组间咬合力的变化，精神作用，情绪变化,和其他不良事件。与基线和安慰剂组相比，两个CBD组均显着减少了VAS疼痛，在180分钟的时间点，与基线疼痛相比，最大的VAS疼痛中位数减少了73％（P<0.05）。与CBD10相比，CBD20的疼痛缓解速度更快（给药后15分钟与30分钟相比）。两组在180分钟时达到最大疼痛缓解。CBD10需要治疗的数量为3.1，CBD20需要治疗的数量为2.4。组内比较显示，两个CBD组的咬合力均显着增加（P<0.05），而安慰剂组则没有增加（P>0.05）。与安慰剂组相比，CBD20导致90分钟和180分钟时间点的平均咬合力变化百分比显着差异（P<0.05）。与安慰剂相比，镇静,腹泻,腹痛与CBD组显著相关(P<0.05)。没有其他明显的精神或情绪变化影响。这项随机试验提供了第一个临床证据，证明口服CBD可以是治疗牙齿疼痛的有效和安全的镇痛药。
