Intravenous dextrose versus ondansetron for prevention of postoperative vomiting in children: a randomized non-inferiori
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REPORTS OF ORIGINAL INVESTIGATIONS
Intravenous dextrose versus ondansetron for prevention of postoperative vomiting in children: a randomized noninferiority trial Dextrose intraveineux versus ondanse´tron pour la pre´vention des vomissements postope´ratoires chez l’enfant : une e´tude randomise´e de non-infe´riorite´ . Jonathan Gamble, MD, FRCPC . Andrea Vasquez-Camargo, MD, CCFP, MSc Kelly A. Fedoruk, MD, FRCPC . Hyun J. June Lim, PhD . Prosanta K. Mondal, PhD . Juan Martinez, RN, BSN, BSc . Grant G. Miller, MD, FRCSC Received: 25 July 2019 / Revised: 22 April 2020 / Accepted: 22 April 2020 Ó Canadian Anesthesiologists’ Society 2020
Abstract Background 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. Aim The primary purpose was to study the efficacy of intraoperative intravenous dextrose for antiemetic prophylaxis in children undergoing ambulatory surgery. Methods 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 mgkg-1 iv) and ondansetron (0.05 mgkg-1 iv); the intervention group received dexamethasone (0.15 mgkg-1 iv) and intravenous 5% dextrose in 0.9% normal saline according to a weightA. Vasquez-Camargo, MD, CCFP, MSc (&) Department of Academic Family Medicine, University of Saskatchewan, 172-1621 Albert Street, Regina, SK S4P 2S5, Canada e-mail: [email protected] J. Gamble, MD, FRCPC Department of Anesthesiology, Perioperative Medicine and Pain Management, University of Saskatchewan, Saskatoon, SK, Canada K. A. Fedoruk, MD, FRCPC Department of Anesthesiology, Perioperative Medicine and Pain Management, University of Toronto, Toronto, ON, Canada
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 noninferiority analysis was conducted on the primary outcome using an absolute risk difference of 7.5% as the noninferiority margin. Results 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 nonP. K. Mondal, PhD Clinical Research Support Unit, College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada Department of Surgery, University of Saskatchewan, Saskatoon, SK, Canada J. Martinez, RN, BSN, BSc College of Nursing, University of Saskatchewan, Saskatoon, SK, Canada G. G. Miller, MD, FRCSC Department of Surgery, University of Saskatchewan, Saskatoon, SK, Canada
H. J. J. Lim, PhD Community Health and Epidemiology Department, University of Saskatch
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