Dsida R M, Wheeler M, Birmingham P K, Henthorn T K, Avram M J, Enders-Klein C, Maddalozzo J, Coté C J
Department of Pediatric Anesthesia, Children's Memorial Hospital, Chicago, IL 60614, USA.
Anesth Analg. 1998 Jan;86(1):66-70. doi: 10.1097/00000539-199801000-00013.
We assessed the safety and efficacy of oral transmucosal fentanyl citrate (Fentanyl Oralet; Abbott Laboratories, Abbott Park, IL), administered preoperatively to provide both preoperative sedation and postoperative analgesia, in a randomized, double-blind, placebo-controlled study in 40 children, 2-10 yr of age, scheduled for tonsillectomy. In the preoperative holding area, one group (Group O) received Fentanyl Oralet (fentanyl 10-15 micrograms/kg), and the other (Group IV) received only the candy matrix. Patients in Group O received an i.v. injection of saline, and those in Group IV received an i.v. injection of fentanyl (2 micrograms/kg) after removal of the first tonsil. Except for the opioid, patients received a standard anesthetic. Preoperative sedation and cooperation were assessed. Postoperative pain was evaluated using an objective pain scale. Patients in Group O were more sedated but no more cooperative at the induction of anesthesia compared with those in Group IV. No patient vomited preoperatively or experienced preoperative or postoperative desaturation. Time to postanesthesia care unit (PACU) discharge was not different between groups. There was no significant difference in the number of patients requiring morphine in the PACU (6 of 21 in Group O versus 10 of 19 in Group IV). Plasma fentanyl concentrations were not a reliable indicator of the need for postoperative morphine. Among the patients who required morphine postoperatively, there was an 11-fold variation in plasma fentanyl concentrations at the time of morphine administration. Derived pharmacokinetic parameters were similar to those previously reported in children; bioavailability of the fentanyl in Fentanyl Oralet was 0.33. We conclude that premedication with Fentanyl Oralet did not differ with i.v. fentanyl in regard to the induction of anesthesia and postoperative analgesia.
In this double-blind, randomized study, we studied the efficacy of Fentanyl Oralet (10-15 micrograms/kg) preoperatively for providing postoperative analgesia in children undergoing tonsillectomy. We found no incidence of preoperative desaturation or vomiting in any patient. This is in contrast to other studies, in which there was a longer time interval between Fentanyl Oralet completion and induction of anesthesia. The bio-availability of the fentanyl in Fentanyl Oralet was estimated to be 33%, which is less than that reported in adults (approximately 50%). There was no difference in postoperative opioid requirements between patients who received 2 micrograms/kg of fentanyl i.v. and those who received Fentanyl Oralet.
在一项针对40名2至10岁计划行扁桃体切除术的儿童的随机、双盲、安慰剂对照研究中，我们评估了术前给予口腔黏膜芬太尼枸橼酸盐（芬太尼口腔崩解片；雅培实验室，伊利诺伊州雅培公园）以提供术前镇静和术后镇痛的安全性和有效性。在术前等待区，一组（O组）接受芬太尼口腔崩解片（芬太尼10 - 15微克/千克），另一组（IV组）仅接受糖果基质。O组患者在去除第一个扁桃体后静脉注射生理盐水，IV组患者静脉注射芬太尼（2微克/千克）。除阿片类药物外，患者接受标准麻醉。评估术前镇静和配合情况。使用客观疼痛量表评估术后疼痛。与IV组相比，O组患者在麻醉诱导时更镇静但配合程度无差异。没有患者术前呕吐或出现术前或术后低氧血症。两组患者进入麻醉后护理单元（PACU）出院的时间无差异。PACU中需要吗啡的患者数量无显著差异（O组21例中有6例，IV组19例中有10例）。血浆芬太尼浓度不是术后需要吗啡的可靠指标。在术后需要吗啡的患者中，给予吗啡时血浆芬太尼浓度有11倍的差异。推导的药代动力学参数与先前报道的儿童参数相似；芬太尼口腔崩解片中芬太尼的生物利用度为0.33。我们得出结论，在麻醉诱导和术后镇痛方面，芬太尼口腔崩解片与静脉注射芬太尼无差异。
在这项双盲、随机研究中，我们研究了术前使用芬太尼口腔崩解片（10 - 15微克/千克）为行扁桃体切除术的儿童提供术后镇痛的效果。我们发现没有患者出现术前低氧血症或呕吐。这与其他研究不同，在其他研究中，芬太尼口腔崩解片服用结束至麻醉诱导之间的时间间隔更长。芬太尼口腔崩解片中芬太尼的生物利用度估计为33%，低于成人报道的生物利用度（约50%）。静脉注射2微克/千克芬太尼的患者与接受芬太尼口腔崩解片的患者术后阿片类药物需求量无差异。
