Intravenous dextrose versus ondansetron for prevention of postoperative vomiting in children: a randomized non-inferiority trial

Abstract

Postoperative vomiting (POV) in children is frequent. Dextrose-containing intravenous fluids in the perioperative period have shown improvement of POV in adults. Similar studies have not been done in children. The primary purpose was to study the efficacy of intraoperative intravenous dextrose for antiemetic prophylaxis in children undergoing ambulatory surgery. A non-inferiority randomized clinical trial of healthy children (three to nine years old) undergoing ambulatory dental surgery was conducted. The control group received dexamethasone (0.15 mg·kg-1 iv) and ondansetron (0.05 mg·kg-1 iv); the intervention group received dexamethasone (0.15 mg·kg-1 iv) and intravenous 5% dextrose in 0.9% normal saline according to a weight-based maintenance rate. The primary outcome was POV in the postanesthetic care unit (PACU) within two hr after surgery. Secondary outcomes included POV within 24 hr from discharge and unplanned hospital admission. A non-inferiority analysis was conducted on the primary outcome using an absolute risk difference of 7.5% as the non-inferiority margin. Data from 290 patients were analyzed. Demographics and intraoperative anesthetic management were similar between groups. Vomiting in the PACU occurred in 7.6% and 3.5% of the dextrose and ondansetron groups, respectively, with a risk difference of 4.2% (95% confidence interval [CI], -1.0 to 9.5). Given that the upper limit of the 95% CI exceeded our non-inferiority margin, non-inferiority of dextrose compared with ondansetron was not shown. These results do not support the use of intravenous dextrose as a satisfactory alternative to ondansetron to prevent POV in ambulatory pediatric dental surgery patients. www.clinicaltrials.gov (NCT01912807); registered 18 July 2013.