Purpose: The purpose of this study was to evaluate the safety and efficacy of three different intravenous (IV) doses of palonosetron compared with placebo for the prevention of postoperative nausea and vomiting (PONV) in children undergoing dental rehabilitation under general anesthesia (DRGA) in the first 24 hours after discharge.
Methods: A total of 286 children who were classified with an American Society of Anesthesiologists physical status of I and II, between three and 13 years old (mean=6.13 years old), and undergoing DRGA were enrolled in this study. The children were randomized to receive one of the three doses of palonosetron (0.0025 mg, 0.0050 mg, or 0.0075 mg) or placebo immediately before induction of anesthesia.
Results: Compared with placebo, the incidence of PONV was significantly lower in the palonosetron groups (P<.05). However, there were no statistically significant differences among the palonosetron groups regarding the number of children with PONV during all time periods after anesthesia (P<.05).
Conclusion: A single 0.0025 mg intravenous dose of palonosetron is recommended for further evaluation, as it appears to be an effective dose for prevention of postoperative nausea and vomiting in children undergoing dental rehabilitation under general anesthesia.
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