BACKGROUND:Postoperative nausea and vomiting continue to be a significant problem for pediatric ambulatory surgery patients. Although ondansetron has been demonstrated to be effective in the prophylactic treatment of postoperative nausea and vomiting (surrogate end point) no one has demonstrated a benefit of antiemetic therapy on patient recovery, postanesthesia care unit length of stay, and hospital length of stay (nonsurrogate end points). In a double-blind manner, the effects of ondansetron, droperidol, and placebo on the incidence of emesis, postanesthesia care unit stay, and hospital discharge time were evaluated in children undergoing dental surgery. METHODS: The subjects were 102 children aged 2-8 years undergoing complete dental restoration. All patients received midazolam before undergoing inhalation induction of anesthesia with N2O/O2 and halothane. Anesthesia was maintained with N2O/O2 and alfentanil. Patients were then randomized to receive ondansetron (0.1 mg/kg), droperidol (75 micrograms/kg), or placebo (normal saline) in a double-blind fashion. At the conclusion of the anesthesia, a trained nurse observer assessed patient recovery and recorded the time patients met specified criteria for postanesthesia care unit and hospital discharge as well as episodes of emesis in the hospital and at home during the first 24 hr after surgery. RESULTS:Ninety-five patients completed the study. The three antiemetic groups were similar with respect to age, weight, length of surgery, dose of alfentanil, and route of preanesthetic medication. The 24-hr incidence of emesis was significantly less with ondansetron (9%) than with placebo (35%) or droperidol (32%). Ondansetron-treated patients had significantly shorter hospital stays than droperidol-treated patients, but recovery parameters were similar between the ondansetron- and placebo-treated patients. CONCLUSIONS:Ondansetron is an effective prophylactic antiemetic agent for children undergoing dental surgery. Compared with droperidol, ondansetron decreases the length of hospital stay, but compared to placebo, there were no differences in the patient recovery parameters.
RCT Entities:
BACKGROUND:Postoperative nausea and vomiting continue to be a significant problem for pediatric ambulatory surgery patients. Although ondansetron has been demonstrated to be effective in the prophylactic treatment of postoperative nausea and vomiting (surrogate end point) no one has demonstrated a benefit of antiemetic therapy on patient recovery, postanesthesia care unit length of stay, and hospital length of stay (nonsurrogate end points). In a double-blind manner, the effects of ondansetron, droperidol, and placebo on the incidence of emesis, postanesthesia care unit stay, and hospital discharge time were evaluated in children undergoing dental surgery. METHODS: The subjects were 102 children aged 2-8 years undergoing complete dental restoration. All patients received midazolam before undergoing inhalation induction of anesthesia with N2O/O2 and halothane. Anesthesia was maintained with N2O/O2 and alfentanil. Patients were then randomized to receive ondansetron (0.1 mg/kg), droperidol (75 micrograms/kg), or placebo (normal saline) in a double-blind fashion. At the conclusion of the anesthesia, a trained nurse observer assessed patient recovery and recorded the time patients met specified criteria for postanesthesia care unit and hospital discharge as well as episodes of emesis in the hospital and at home during the first 24 hr after surgery. RESULTS: Ninety-five patients completed the study. The three antiemetic groups were similar with respect to age, weight, length of surgery, dose of alfentanil, and route of preanesthetic medication. The 24-hr incidence of emesis was significantly less with ondansetron (9%) than with placebo (35%) or droperidol (32%). Ondansetron-treated patients had significantly shorter hospital stays than droperidol-treated patients, but recovery parameters were similar between the ondansetron- and placebo-treated patients. CONCLUSIONS:Ondansetron is an effective prophylactic antiemetic agent for children undergoing dental surgery. Compared with droperidol, ondansetron decreases the length of hospital stay, but compared to placebo, there were no differences in the patient recovery parameters.