Binstock Wendy, Rubin Rachel, Bachman Cathy, Kahana Madelyn, McDade William, Lynch James P
Department of Anesthesia and Critical Care, University of Chicago, IL 60637, USA.
Paediatr Anaesth. 2004 Sep;14(9):759-67. doi: 10.1111/j.1460-9592.2004.01296.x.
The purpose of this study was to evaluate, in the pediatric ambulatory surgical population, the efficacy of: (i) oral transmucosal fentanyl citrate (OTFC), when given preoperatively, to reduce postoperative excitement associated with sevoflurane, and (ii) intravenous ondansetron to reduce postoperative nausea and vomiting (PONV) associated with OTFC.
This randomized, double-blinded, placebo controlled study evaluated the efficacy of OTFC [normal dose (ND) = 10-15 microg x kg(-1) or low dose = 100 microg] compared with placebo in the prevention of postoperative agitation; and the efficacy of ondansetron (0.1 mg x kg(-1) to 4 mg) compared with placebo to reduce PONV associated with OTFC.
There were 125 patients evaluated (2-10 years old, ASA class I or II and weight 10-40 kg). Preoperatively OTFC was associated with an increased likelihood of cooperation at baseline (P = 0.018). Postoperatively there was a higher incidence of vomiting in children that received OTFC. The anxiety/agitation of patients entering the PACU was significantly less in children who received OTFC ND (P < 0.001). This effect decreased over time. Patients with respiratory adverse events related to the study drug were significantly higher in groups who received OTFC, however, they were not of clinical significance. OTFC was associated with delays in time for eligibility to PACU discharge (P = 0.003).
Even though OTFC reduced early postoperative agitation the increase in side effects, namely PONV and prolonged recovery times, limits its clinical usefulness. The study demonstrates the tradeoffs between anxiety and agitation vs vomiting, respiratory events and prolonged recovery times. Ambulatory pediatric patients undergoing procedures in which opioids would be routinely used might benefit the most from OTFC combined with ondansetron as part of the anesthetic technique.
本研究旨在评估在小儿门诊手术人群中：（i）术前给予口服枸橼酸芬太尼（OTFC）以减少与七氟醚相关的术后兴奋，以及（ii）静脉注射昂丹司琼以减少与OTFC相关的术后恶心和呕吐（PONV）的疗效。
这项随机、双盲、安慰剂对照研究评估了OTFC[正常剂量（ND）=10 - 15微克×千克⁻¹或低剂量=100微克]与安慰剂相比预防术后躁动的疗效；以及昂丹司琼（0.1毫克×千克⁻¹至4毫克）与安慰剂相比减少与OTFC相关的PONV的疗效。
共评估了125例患者（2至10岁，ASA分级I或II，体重10至40千克）。术前OTFC与基线时合作可能性增加相关（P = 0.018）。术后接受OTFC的儿童呕吐发生率更高。接受OTFC ND的儿童进入PACU时的焦虑/躁动明显较少（P < 0.001）。这种效果随时间减弱。接受OTFC的组中与研究药物相关的呼吸不良事件患者明显更多，然而，它们不具有临床意义。OTFC与PACU出院资格时间延迟相关（P = 0.003）。
尽管OTFC减少了术后早期躁动，但副作用增加，即PONV和恢复时间延长，限制了其临床实用性。该研究表明了焦虑和躁动与呕吐、呼吸事件和恢复时间延长之间的权衡。接受常规使用阿片类药物手术的门诊小儿患者可能从OTFC与昂丹司琼联合使用作为麻醉技术的一部分中获益最大。
