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.
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.