Background and Aims

Chronic opioid use increases tolerance to sedatives. Diphenhydramine is recommended for difficult-to-sedate patients during endoscopic procedures. We hypothesized that the addition of diphenhydramine to midazolam and fentanyl would improve objective and subjective measures of procedural sedation.

Methods

This randomized, double-blind, placebo-controlled trial included patients on chronic opioids undergoing colonoscopy. Patients were randomized to receive intravenous 50 mg of diphenhydramine (N=61) or placebo (N=58), in addition to fentanyl and midazolam. Baseline characteristics, amount of fentanyl and midazolam, procedure times, and adverse events were recorded. Quality of sedation was assessed by the physician and nurse. Patients rated pain and amnesia on a 10-point scale.

Results

There was no difference in amounts of fentanyl (125.4 ± 56.2 μg vs 126.9 ± 53.5 μg, p=0.88) and midazolam (4.9 ± 2.1 mg vs 5 ± 1.9 mg, p=0.79) used. The mean sedation scores from the physician (6.2 ± 1.1 vs 5.3 ± 1.2, p=0.0002) and nurses (5.6 ± 1.5 vs 5.1 ± 1.4, p=0.04) were statistically significant in favor of the diphenhydramine arm. Patient scores for pain (2.05 ± 2.17 vs 3.09 ± 3.95, p=0.047) and amnesia (7.8 ± 3.4 vs 6.5 ± 3.8, p=0.047) favored the group that received diphenhydramine. Qualitative assessment showed no significant difference between groups. There was no difference in induction time (p=0.86), procedure duration (p=0.98), or recovery time (p=0.16). Hypotensive episodes were more common in the placebo group (p=0.027).

Conclusions

In patients on chronic opioid therapy, administration of diphenhydramine does not allow for lower doses of procedural sedatives but improves quality of sedation without increasing the number of adverse events.

中文翻译：

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苯海拉明在接受慢性阿片类药物治疗的患者中作为结肠镜检查辅助镇静剂的用途：一项随机对照试验

背景和目标

长期使用阿片类药物可增加对镇静剂的耐受性。内镜手术期间，对于难以镇静的患者，建议使用苯海拉明。我们假设向咪达唑仑和芬太尼中添加苯海拉明将改善手术镇静的客观和主观措施。

方法

这项随机，双盲，安慰剂对照试验包括接受结肠镜检查的慢性阿片类药物患者。除芬太尼和咪达唑仑外，患者随机接受静脉注射50 mg苯海拉明（N = 61）或安慰剂（N = 58）。记录基线特征，芬太尼和咪达唑仑的量，手术时间和不良事件。镇静质量由医师和护士评估。患者对疼痛和健忘症的评分为10分。

结果

芬太尼（125.4±56.2μgvs 126.9±53.5μg，p = 0.88）和咪达唑仑（4.9±2.1 mg vs 5±1.9 mg，p = 0.79）的使用量无差异。医师（6.2±1.1 vs 5.3±1.2，p = 0.0002）和护士（5.6±1.5 vs 5.1±1.4，p = 0.04）的平均镇静评分在统计学上均显着高于苯海拉明组。疼痛评分（2.05±2.17 vs 3.09±3.95，p = 0.047）和健忘症（7.8±3.4 vs 6.5±3.8，p = 0.047）的患者评分偏高于苯海拉明组。定性评估显示两组之间无显着差异。诱导时间（p = 0.86），手术时间（p= 0.98）或恢复时间（p = 0.16）。降压发作在安慰剂组中更为常见（p = 0.027）。

结论

在接受慢性阿片类药物治疗的患者中，苯海拉明的给药不允许使用较低剂量的程序性镇静剂，但可以改善镇静剂的质量，而不会增加不良事件的数量。