ABSTRACT
STUDY OBJECTIVE: To evaluate the safety and efficacy of oral transmucosal fentanyl citrate (OTFC) as a noninvasive method of providing analgesia and sedation for patients in the emergency department. DESIGN: Prospective, nonblinded. SETTING: ED of a tertiary care university hospital. TYPE OF PARTICIPANTS: Ten patients, 6 to 34 years old, with acute painful conditions requiring treatment in the ED. INTERVENTIONS: Premedication with OTFC and local anesthetic prior to incision or wound closure. MEASUREMENTS AND MAIN RESULTS: Pain and activity (sedation) scores, vital signs (including systolic and diastolic arterial blood pressures, heart and respiratory rates, and pulse oximetry-determined oxygen saturation) were measured before and at two- to ten-minute intervals during and after OTFC consumption. All patients accepted OTFC. Patients received an average of 13.7 +/- 2.5 micrograms/kg of fentanyl citrate in 11.8 +/- 6.8 minutes. Decreases in pain were reported in two patients in two minutes and by all patients 14 minutes after beginning OTFC consumption. Sixty percent of patients became drowsy or sedated 12 to 30 minutes after beginning OTFC. Vital signs and oxygen saturation changes were small and not clinically significant. The most important side effects were pruritus (30%), nausea (20%), and dizziness and dry mouth (40%). All were considered mild and not disturbing, although one patient required post-procedure antiemetic therapy for recurrent vomiting. The mean time to discharge from the ED was 139 +/- 54 minutes after receiving OTFC. CONCLUSION: OTFC may be useful in providing rapid, noninvasive analgesia and sedation in the ED and deserves further evaluation.
Subject(s)
Fentanyl/administration & dosage , Pain/drug therapy , Administration, Oral , Adolescent , Adult , Child , Drug Evaluation , Emergencies , Female , Fentanyl/adverse effects , Humans , Male , Preanesthetic Medication , Prospective StudiesABSTRACT
Two doses (10-15 micrograms.kg-1, Group I, and 15-20 micrograms.kg-1, Group II) of oral transmucosal fentanyl citrate (OTFC) plus a placebo (Group III) were evaluated for premedication in 105 healthy children, aged 2 to 13 yr, undergoing short (less than 1 hr) operations in the hospital short-stay unit. The study was randomized and double-blinded and 91 of the 105 children also received droperidol, 25 micrograms.kg-1 IV, after induction of anaesthesia with halothane and N2O in oxygen. Both doses of OTFC produced significantly greater sedation (first present at 20 min) and anxiolysis (first present in Group I at 40 min) than the placebo. Recovery times were similar in the three groups and analgesic requirements in the recovery room were significantly lower in Group I than Group III. Both OTFC groups took longer to tolerate oral fluids in the postoperative discharge unit than the placebo group and this caused patients in Group I to have a delayed discharge from the hospital compared to Group III. Preoperative pruritus occurred significantly more frequently in Groups I and II (58 and 76 per cent, respectively) than Group III (23 per cent). Although the incidences of nausea and vomiting tended to be slightly higher in the OTFC groups in the preoperative holding and postoperative discharge units, the differences among the groups were not statistically significant. Likewise droperidol did not reduce the incidence of postoperative nausea or vomiting. The data indicate that OTFC may be a safe and effective premedicant in paediatric patients having short operations but delays discharge from the hospital (by 30-50 min) by delaying the time patients tolerate fluids early after operation.
