EVALUATION OF DEXTROSE AS AN EFFECTIVE ANTI-EMETIC IN PEDIATRIC PATIENTS UNDERGOING GENERAL ANESTHESIA FOR AMBULATORY DENTAL PROCEDURES: A NON-INFERIORITY, RANDOMIZED CONTROL TRIAL

Abstract

Vomiting is a frequent postoperative complication in children receiving general anesthesia, with reported incidences of 8.9 to 42%, and is the fourth most common indication for unexpected hospital admission. Intravenous fluids containing dextrose are commonly used in children. Although studies using these intravenous fluids in the perioperative period have shown improvement in the postoperative recovery, including reducing the incidence of postoperative vomiting in adults, similar studies have not been done in pediatric patients. In this dissertation, I have described the efficacy of intraoperative intravenous dextrose compared to ondansetron as a prophylactic antiemetic in children undergoing ambulatory dental procedures under general anesthesia. A double-blinded randomized control trial was conducted of 300 healthy children, aged 3 to 9 years without known risk factors for postoperative vomiting, who underwent ambulatory dental procedures under general anesthesia. Patients were randomized into two groups based on antiemetic prophylaxis. The control group received dexamethasone (0.15 mg/kg IV) and ondansetron (0.05 mg/kg IV); the intervention group received dexamethasone (0.15 mg/kg IV) and intravenous 5% Dextrose in 0.9% normal saline maintenance fluid. The approach used to analyze the data was based on an intention to treat analysis. The primary outcome, emesis in the post-anaesthetic care unit within 2 hours after surgery, was compared using Chi-Square. The secondary outcomes were analysed by T-test and non-parametric analysis when appropriate. A non-inferiority analysis of intraoperative intravenous dextrose relative to ondansetron was conducted with δ = 7.5 % as the non-inferiority limit. 290 patients were analyzed (intervention group N=144, control group N=146). Demographics and intraoperative anaesthetic management were similar between groups. Emesis in PACU was also similar between groups. Emesis in the post-anesthetic care unit was not significantly different between groups (p = 0.11) with a postoperative vomiting proportion of 7.64 % and 3.45% for the intervention and control groups respectively, and a proportion difference of 4.2% (CI 95% -1.0, 9.5). The results of this study were inconclusive in demonstrating that intravenous dextrose is not less effective than ondansetron in preventing postoperative vomiting