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Anesthesia & Analgesia, Vol 83, 1200-1205, Copyright © 1996 by International Anesthesia Research Society

GENERAL ARTICLES

The safety and efficacy of oral transmucosal fentanyl citrate for preoperative sedation in young children

RH Epstein, HG Mendel, TA Witkowski, R Waters, KM Guarniari, AT Marr and JB Lessin
Department of Anesthesiology, Jefferson Medical College, Philadelphia, Pennsylvania 19107, USA.

Oral transmucosal fentanyl citrate (OTFC) is a labeled preoperative pediatric sedative. Doses greater than 15 micrograms/kg are associated with a high incidence of post-operative nausea and vomiting and occasional respiratory depression. We studied the safety and efficacy of OTFC in children 6 yr old and younger at a dose of 15 micrograms/kg. Nineteen patients undergoing surgery associated with postoperative pain were randomized to receive OTFC/intravenous (IV) saline or placebo lozenge/IV fentanyl. After 45 min, patients receiving OTFC became more sedated than the placebo group, but there were no differences in cooperation, apprehension, parental separation, or induction cooperation scores. Preoperatively, neither respiratory depression nor oxygen desaturation occurred. Nine of 10 OTFC patients developed mild pruritus, and three of 10 OTFC patients vomited preoperatively; neither complication occurred in the placebo group. (The high incidence of preoperative vomiting led to the termination of the protocol before the anticipated enrollment of 40 patients.) General anesthesia was induced via a mask, followed by a propofol infusion. Spo2 and respiratory rate were monitored, and sedation, apprehension, cooperation, ease of parental separation, and induction cooperation were scored. One OTFC patient developed rigidity during induction. Emergence and recovery were not delayed by OTFC despite a 50% incidence of postoperative vomiting. We do not recommend the use of OTFC in a 15 micrograms/kg dose as a routine preoperative sedative in children 6 yr old and younger.


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Lippincott, Williams & Wilkins Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins and Stanford University Libraries' HighWire Press®. Copyright 1996 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999 HighWire Press
Copyright © 1996 by the International Anesthesia Research Society.