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少即是少:一项比较纳布啡谨慎给药方案和快速给药方案的随机对照试验。

Less IS less: a randomised controlled trial comparing cautious and rapid nalbuphine dosing regimens.

作者信息

Woollard M, Whitfield R, Smith K, Jones T, Thomas G, Thomas G, Hinton C

机构信息

Pre-hospital Emergency Research Unit, Welsh Ambulance Services NHS Trust/University of Wales College of Medicine, Cardiff, UK.

出版信息

Emerg Med J. 2004 May;21(3):362-4. doi: 10.1136/emj.2004.014324.

Abstract

OBJECTIVE

This study aimed to determine which of two paramedic administered nalbuphine dosing regimens combined the greater analgesic effect with the minimum of adverse events.

METHODS

Patients suffering from chest pain or trauma were randomised to receive either a rapid dosing regimen (10 mg over 30 seconds, repeated once after three minutes if pain score remained above three) or a cautious regimen (5 mg over two minutes, repeated at three minute intervals if pain score remained above three to a maximum dose of 20 mg). Data were collected on analgesic effectiveness, changes in vital signs, and patient reported side effects.

RESULTS

The pain score fell by a mean of 4.29 and 3.49 in the rapid and cautious regimen groups respectively (difference = 0.79, 95% CI 0.09 to 1.5, p = 0.028). However, over half the patients in both groups continued to suffer significant pain on arrival at hospital. There were no significant changes in vital signs after nalbuphine, but there was a greater incidence of patient reported drowsiness in rapid regimen patients (42% compared with 21%, 95% CI = 6.96 to 34.12%, p = 0.003).

CONCLUSION

A rapid dosing regimen of nalbuphine using 10 mg increments is more effective than and equally as safe as a cautious regimen using 5 mg increments. Further research is required to determine if a maximum dose exceeding 20 mg would result in fewer patients continuing to suffer significant pain before arrival at hospital.

摘要

目的

本研究旨在确定两种由护理人员给予的纳布啡给药方案中,哪一种能在将不良事件降至最低的同时,产生更强的镇痛效果。

方法

将胸痛或创伤患者随机分组,分别接受快速给药方案(30秒内给予10毫克,若疼痛评分仍高于3分,则在三分钟后重复一次)或谨慎给药方案(两分钟内给予5毫克,若疼痛评分仍高于3分,则每隔三分钟重复给药,最大剂量为20毫克)。收集有关镇痛效果、生命体征变化以及患者报告的副作用的数据。

结果

快速给药方案组和谨慎给药方案组的疼痛评分分别平均下降了4.29和3.49(差值 = 0.79,95%置信区间为0.09至1.5,p = 0.028)。然而,两组中超过半数的患者在抵达医院时仍遭受明显疼痛。纳布啡给药后生命体征无显著变化,但快速给药方案组中患者报告的嗜睡发生率更高(42%,而谨慎给药方案组为21%,95%置信区间为6.96%至34.12%,p = 0.003)。

结论

采用10毫克递增剂量的纳布啡快速给药方案比采用5毫克递增剂量的谨慎给药方案更有效,且安全性相当。需要进一步研究以确定超过20毫克的最大剂量是否会使更少患者在抵达医院前继续遭受明显疼痛。

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