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Published on: August 4, 2023
Addition of droperidol to prophylactic ondansetron and dexamethasone in children at high risk for postoperative
N Bourdaud1, C François1, O Jacqmarcq2
1Service d'Anesthésie Réanimation, Hôpital Universitaire Necker, Université Paris Descartes Sorbonne Paris Cité, Assistance Publique-Hôpitaux de Paris, Paris, France.
Insights
Adding droperidol to dexamethasone and ondansetron did not reduce postoperative vomiting in children. The combination of dexamethasone and ondansetron is recommended for high-risk pediatric patients to prevent nausea and vomiting.
Area of Science:
- Anesthesiology
- Pediatric Pharmacology
- Clinical Trial Research
Background:
- Postoperative nausea and vomiting (PONV) is a common concern in pediatric surgery.
- The combination of dexamethasone (DEX), ondansetron (OND), and droperidol (DRO) is effective in adults but less studied in children.
- High-risk pediatric patients require optimized antiemetic prophylaxis.
Purpose of the Study:
- To evaluate the efficacy of adding droperidol to DEX and OND for preventing postoperative vomiting (POV) in high-risk children.
- To assess the impact of droperidol on the incidence of POV and adverse events.
- To determine the optimal antiemetic regimen for pediatric patients undergoing elective surgery.
Main Methods:
- A randomized controlled trial involving children aged 3-16 undergoing elective surgery.
- Group A received DEX, OND, and placebo; Group B received DEX, OND, and DRO.
- Primary outcome: incidence of POV within 24 hours; Secondary outcome: adverse events.
Main Results:
- No significant difference in POV incidence between groups (10.5% vs. 11.1%, P=0.86).
- Fewer adverse events in the placebo group (2% vs. 8%, P=0.01), primarily drowsiness and headache.
- Droperidol did not provide additional benefit in reducing POV but increased adverse events.
Conclusions:
- Adding droperidol to DEX and OND does not improve POV prevention in high-risk children.
- The combination of DEX and OND is recommended for high-risk pediatric patients.
- DEX and OND combination offers a favorable risk-benefit profile for pediatric PONV prophylaxis.
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.
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