Feld L H, Champeau M W, van Steennis C A, Scott J C
Department of Anesthesia, Stanford University School of Medicine, California.
Anesthesiology. 1989 Sep;71(3):374-7.
Initial studies have suggested that oral transmucosal fentanyl citrate (OTFC) in a dose of 15-20 micrograms/kg may be a safe and effective preanesthetic medication in children and adults, but this has not been demonstrated in a randomized, double-blind fashion. The purpose of this study was to determine in a randomized, double-blind manner, the efficacy of a lollipop containing fentanyl citrate as a preanesthetic medication before surgery in children. Forty health ASA physical status 1 or 2 children 3-12 yr of age were divided randomly and in double-blind fashion into two groups. Group 1 received the lollipop containing OTFC and group 2 received a placebo lollipop. An appropriate size lollipop was chosen so that if the patient received fentanyl, the total dose would be 15-20 micrograms/kg. Anxiety, sedation, and separation scores were assessed preoperatively and ease of induction was rated. Oxygen saturation and respiratory rate were monitored. Time intervals from preanesthetic to induction and from recovery room (PACU) admission to discharge were noted. Recovery room behavior was assessed upon admission and discharge. Complications and the need for postoperative opioids were noted. OTFC produced significantly more sedation and less anxiety compared with that following placebo. Respiratory rate was significantly decreased in the OTFC group, but oxygen saturation was not significantly different between groups. Anxiety and separation scores and the quality of induction were better in the OTFC group. There was a higher incidence of nausea and pruritus in the fentanyl group. OTFC did not prolong the PACU stay.
初步研究表明，剂量为15 - 20微克/千克的口腔黏膜枸橼酸芬太尼（OTFC）可能是儿童和成人安全有效的麻醉前用药，但尚未通过随机双盲方式得到证实。本研究的目的是以随机双盲方式确定含枸橼酸芬太尼的棒棒糖作为儿童手术前麻醉前用药的疗效。40名健康的美国麻醉医师协会（ASA）身体状况为1或2级、年龄在3 - 12岁的儿童被随机双盲分为两组。第1组接受含OTFC的棒棒糖，第2组接受安慰剂棒棒糖。选择合适大小的棒棒糖，以便如果患者接受芬太尼，总剂量为15 - 20微克/千克。术前评估焦虑、镇静和分离评分，并对诱导的难易程度进行评级。监测血氧饱和度和呼吸频率。记录从麻醉前到诱导以及从恢复室（PACU）入院到出院的时间间隔。入院和出院时评估恢复室行为。记录并发症和术后使用阿片类药物的需求。与安慰剂相比，OTFC产生的镇静作用明显更强，焦虑程度更低。OTFC组的呼吸频率显著降低，但两组之间的血氧饱和度无显著差异。OTFC组的焦虑和分离评分以及诱导质量更好。芬太尼组恶心和瘙痒的发生率更高。OTFC并未延长PACU停留时间。
