Fahringer David L, Goodwin Salvatore R, Warde Mary K, Ye Gang, Blackwelder Bryan, Ajala Adebisi M, Gurgis Fahmy S
Nemours Children's Clinic, Jacksonville, FL 32207, USA.
Paediatr Anaesth. 2010 Jun;20(6):545-52. doi: 10.1111/j.1460-9592.2010.03318.x. Epub 2010 Apr 23.
In this prospective, randomized, double-blind, controlled trial, our primary objective was to assess the effect of a 3 : 1 mixture of propofol and thiopental in reducing pain on injection in children. Our hypothesis was that a 3 : 1 mixture of propofol and thiopental (treatment) would reduce the incidence of pain on injection to 20% compared to the expected incidence of 40% in the control group of an 11 : 1 mixture of propofol and 2% lidocaine.
Study subjects were patients 12-17 years old who were scheduled to undergo surgery and general anesthesia. Pain was assessed by a single-blinded observer present in the operating room. The major statistical method used in the analysis was multiple logistic regression.
Among the 164 children analyzed, 96 patients (58.5%) were male. The average age was 14.3 (sd = 1.65). The incidence of pain in the control group was 32.1% (26/81), compared to 25.3% (21/83) in the treatment group. The logistic regression analysis showed that there was not sufficient evidence that the treatment group was better than control group in reducing pain (P = 0.24). There were no significant differences in postoperative recovery time, nausea, vomiting, or blood pressure between the two groups (all P values >0.10).
There was not sufficient evidence to show that a 3 : 1 mixture of propofol and thiopental was better than an 11 : 1 volume admixture of propofol and lidocaine in reducing the incidence of pain on injection to 20%.
在这项前瞻性、随机、双盲、对照试验中,我们的主要目的是评估丙泊酚与硫喷妥钠3∶1混合液在减轻儿童注射痛方面的效果。我们的假设是,与丙泊酚和2%利多卡因11∶1混合液的对照组预计40%的注射痛发生率相比,丙泊酚与硫喷妥钠3∶1混合液(治疗组)可将注射痛发生率降低至20%。
研究对象为计划接受手术及全身麻醉的12 - 17岁患者。由手术室中一名单盲观察者评估疼痛情况。分析中使用的主要统计方法是多元逻辑回归。
在分析的164名儿童中,96名患者(58.5%)为男性。平均年龄为14.3岁(标准差 = 1.65)。对照组的疼痛发生率为32.1%(26/81),治疗组为25.3%(21/83)。逻辑回归分析表明,没有足够证据证明治疗组在减轻疼痛方面优于对照组(P = 0.24)。两组在术后恢复时间、恶心、呕吐或血压方面均无显著差异(所有P值>0.10)。
没有足够证据表明丙泊酚与硫喷妥钠3∶1混合液在将注射痛发生率降低至20%方面优于丙泊酚与利多卡因11∶1体积混合液。