PURPOSE: The purpose of this study was to measure the safety and efficacy of propofol combined with fentanyl as sedative agents during third molar outpatient surgery. PATIENTS AND METHODS: A double-blind, prospective, randomized clinical trial involving 57 patients undergoing removal of third molars under intravenous sedation between November 1994 and December 1995 was performed. Patients randomly received either propofol and fentanyl (P + F, th = 24) or midazolam and fentanyl (M + F, M = 33). Patient demographics, Corah anxiety scores, and physiologic parameters were determined preoperatively. All medications were titrated to the same clinical end point for sedation. Intraoperative physiologic parameters, cooperation, alertness, and pain scores were assessed. Postoperative recovery and degree of amnesia also were determined. RESULTS: There were no significant differences in either patient demographics or surgical characteristics between groups. The P + F group was significantly less cooperative than the M + F group. Pain during injection of propofol was a significant adverse side effect. Both groups experienced a small percentage of apneic episodes, but mechanical ventilation was never required. There were no differences in recovery between groups as measured by the Treiger dot test and psychomotor recovery scores. The degree of anterograde amnesia was greater for the M + F group, although the difference was not statistically significant. Sedation was rated good to excellent by the patient, surgeon, and observer, and there were no statistically significant differences between groups. CONCLUSION:Propofol appears to be a safe and efficacious drug for use during outpatient oral surgical procedures.
RCT Entities:
PURPOSE: The purpose of this study was to measure the safety and efficacy of propofol combined with fentanyl as sedative agents during third molar outpatient surgery. PATIENTS AND METHODS: A double-blind, prospective, randomized clinical trial involving 57 patients undergoing removal of third molars under intravenous sedation between November 1994 and December 1995 was performed. Patients randomly received either propofol and fentanyl (P + F, th = 24) or midazolam and fentanyl (M + F, M = 33). Patient demographics, Corah anxiety scores, and physiologic parameters were determined preoperatively. All medications were titrated to the same clinical end point for sedation. Intraoperative physiologic parameters, cooperation, alertness, and pain scores were assessed. Postoperative recovery and degree of amnesia also were determined. RESULTS: There were no significant differences in either patient demographics or surgical characteristics between groups. The P + F group was significantly less cooperative than the M + F group. Pain during injection of propofol was a significant adverse side effect. Both groups experienced a small percentage of apneic episodes, but mechanical ventilation was never required. There were no differences in recovery between groups as measured by the Treiger dot test and psychomotor recovery scores. The degree of anterograde amnesia was greater for the M + F group, although the difference was not statistically significant. Sedation was rated good to excellent by the patient, surgeon, and observer, and there were no statistically significant differences between groups. CONCLUSION:Propofol appears to be a safe and efficacious drug for use during outpatient oral surgical procedures.