Granry J C, Rod B, Monrigal J P, Merckx J, Berniere J, Jean N, Boccard E
Département Anesthésie-Réanimation, CHU 49036, Angers, France.
Paediatr Anaesth. 1997;7(6):445-9. doi: 10.1046/j.1460-9592.1997.d01-121.x.
The analgesic efficacy and safety of propacetamol, an injectable prodrug of acetaminophen, (paracetamol) were studied in 87 children (36 boys, 51 girls; age 6-13; mean age 9.5 years) immediately after limb surgery. Using a double-blind, randomized, parallel group design, the effects of a single IV infusion of 30 mg.kg-1 propacetamol (i.e. 15 mg.kg-1 acetaminophen) were compared with a single injection of placebo (PL). Efficacy was assessed on pain scores rated on a four-point verbal scale, a five-point visual scale (faces) and on a four-point relief verbal scale before administration (T0) and 0.25, 0.5, 1, 2, 3, 4, 5, 6 h after administration. At the end the global efficacy was rated by the physician on a five-point verbal scale. Propacetamol was statistically superior to placebo on all assessment criteria. Seven side-effects were recorded: five in the propacetamol group and two in the placebo group. 30 mg.kg-1 propacetamol provided a significantly greater analgesic effect than placebo in children after orthopaedic surgery.
在87名儿童(36名男孩,51名女孩;年龄6 - 13岁;平均年龄9.5岁)肢体手术后即刻,对醋氨酚(扑热息痛)的注射用前体药物丙帕他莫的镇痛效果及安全性进行了研究。采用双盲、随机、平行组设计,将单次静脉输注30mg·kg-1丙帕他莫(即15mg·kg-1醋氨酚)的效果与单次注射安慰剂(PL)进行比较。在给药前(T0)以及给药后0.25、0.5、1、2、3、4、5、6小时,根据四分语言量表、五分视觉量表(面部表情)和四分缓解语言量表对疼痛评分来评估疗效。最后由医生根据五分语言量表对总体疗效进行评分。在所有评估标准上,丙帕他莫在统计学上均优于安慰剂。记录到7例副作用:丙帕他莫组5例,安慰剂组2例。在骨科手术后儿童中,30mg·kg-1丙帕他莫比安慰剂具有显著更强的镇痛效果。