Bahal-O'Mara N, Nahata M C, Murray R D, Linscheid T R, Fishbein M, Heitlinger L A, Li B U, McClung H J, Potter C, Lininger B
College of Pharmacy, Ohio State University, Columbus 43210.
Eur J Clin Pharmacol. 1994;47(4):319-23. doi: 10.1007/BF00191162.
We conducted a randomized, double-blind trial evaluating the efficacy and safety of meperidine 2 mg.kg-1 (M) and meperidine 2 mg.kg-1 plus midazolam 0.05 mg.kg-1 (M + M) in 40 pediatric outpatients (age 1 to 17 years) undergoing upper endoscopy procedures. The physician and nurse performing the procedure were asked to rate cooperation, emotional status, drowsiness, and overall efficacy. A blinded observer recorded the frequency of negative behaviors indicating distress, vital signs, and oxygen saturation before, during, and after the procedure. No significant differences were noted in the overall efficacy of the regimens. Good or excellent efficacy was noted in 15 of 21 children (71%) in the M group and 15 of 19 children (79%) in the M + M group by physicians; nurses assigned a good or excellent rating for 14 of 21 (67%) and 13 of 19 (68%) in the M and M + M groups, respectively. Immediately following the procedure, amnesia was noted in 4 of 17 (23%) patients who received M versus 14 of 18 (78%) patients who received M + M (P = 0.002). Of the children who received M + M, the amnesia tended to occur more frequently in older children (> 11 years, 8 children, rate of amnesia 100%) than in younger children (< or = 11 years, 6 of 10 evaluable children, rate of amnesia 60%). There was no significant difference between the frequency of negative behaviors, rate of adverse effects, or changes in vital signs or oxygen saturation noted with the two drug regimens.(ABSTRACT TRUNCATED AT 250 WORDS)
我们进行了一项随机双盲试验,评估2mg.kg-1哌替啶(M)以及2mg.kg-1哌替啶加0.05mg.kg-1咪达唑仑(M+M)对40名接受上消化道内镜检查的儿科门诊患者(年龄1至17岁)的疗效和安全性。要求实施检查的医生和护士对患者的配合度、情绪状态、嗜睡程度和总体疗效进行评分。一名盲法观察者记录了检查前、检查期间和检查后表明痛苦的负面行为发生频率、生命体征和血氧饱和度。两种治疗方案的总体疗效无显著差异。医生评定M组21名儿童中有15名(71%)疗效良好或极佳,M+M组19名儿童中有15名(79%)疗效良好或极佳;护士对M组21名中的14名(67%)和M+M组19名中的13名(68%)评定为良好或极佳。检查结束后立即发现,接受M治疗的17名患者中有4名(23%)出现失忆,而接受M+M治疗的18名患者中有14名(78%)出现失忆(P=0.002)。在接受M+M治疗的儿童中,年龄较大的儿童(>11岁,8名儿童,失忆率100%)比年龄较小的儿童(≤11岁,10名可评估儿童中的6名,失忆率60%)更容易出现失忆。两种药物治疗方案在负面行为发生频率、不良反应发生率或生命体征及血氧饱和度变化方面无显著差异。(摘要截选至250字)