Addition of droperidol to prophylactic ondansetron and dexamethasone in children at high risk for postoperative vomiting. A randomized, controlled, double-blind study

Autor: J Jean, Jean-Marc Tréluyer, N Bouazza, F Boutin, C François, Nathalie Bourdaud, Gilles Orliaguet, C Studer, C Engrand-Donal, E Guyot, Jean-Michel Devys, Marie-Laurence Guye, O Jacqmarcq
Rok vydání: 2017
Předmět:
Zdroj: British Journal of Anaesthesia. 118:918-923
ISSN: 0007-0912
Popis: Background The combination of dexamethasone (DEX), ondansetron (OND) and droperidol (DRO) is efficacious in preventing postoperative nausea and vomiting in adults, but has not been well assessed in children. Methods Children undergoing elective surgery under general anaesthesia and considered at high risk for postoperative vomiting (POV) were randomly assigned to receive a combination of DEX, OND and placebo (Group A) or a combination of DEX, OND and DRO (Group B). The primary outcome was the incidence of POV during the first 24 hours after surgery. We hypothesized that the addition of DRO to the standard antiemetic prophylaxis would provide a further 15% reduction in the residual risk for POV. The secondary outcome considered was any adverse event occurring during the study. Results One hundred and fifty-three children, aged three to 16 years, were randomized to Group A and 162 to Group B. The overall incidence of POV did not differ significantly between the two groups, with 16 patients in Group A (10.5%) and 18 in Group B (11.1%) presenting with one or more episodes of POV, P=0.86. Fewer patients presented with adverse events in Group A (2%) compared with Group B (8%), P=0.01. Drowsiness and headache were the principal adverse events reported. Conclusions The addition of DRO to a combination of OND and DEX did not decrease POV frequency below that obtained with the two-drug combination in children at high risk of POV, but increased the risk of drowsiness. The combination of DEX and OND should be recommended in children with a high risk of POV. Clinical trial registration NCT01739985.
Databáze: OpenAIRE