-
Randomized Controlled Trial Clinical Trial
Ondansetron dose response curve in high-risk pediatric patients.
- C D Lawhorn, P J Kymer, F C Stewart, J M Stoner, R Shirey, and P Volpe.
- Division of Pediatric Anesthesia, Arkansas Children's Hospital, Little Rock 72202-3591, USA.
- J Clin Anesth. 1997 Dec 1;9(8):637-42.
Study ObjectiveTo establish a dose-response relationship for ondansetron, and to evaluate any effects of oral premedication with metoclopramide in pediatric patients undergoing tonsillectomy and adenoidectomy and strabismus surgery.DesignProspective, randomized, double blind study.SettingUniversity affiliated, 280-bed pediatric hospital.Patients320 ASA physical status l and II patients between the ages of 2 and 12 years undergoing tonsillectomy and adenoidectomy or strabismus surgery.InterventionsPatients were randomized to eight investigational groups. Patients in all eight groups underwent a standard anesthetic. Groups 1, 2, 3, and 4 received intravenous (i.v.) saline or i.v. ondansetron at doses of 0.05 mg/kg, 0.1 mg/kg and 0.15 mg/kg, respectively. Groups 5, 6, 7, and 8 received oral metoclopramide 0.15 mg/kg as well as i.v. saline, and ondansetron 0.05 mg/kg, 0.1 mg/kg, or 0.15 mg/kg. Patients were evaluated for emetic episodes prior to and following discharge.Measurements And Main ResultsAll doses of ondansetron 0.05 mg/kg, 0.1 mg/kg, and 0.15 mg/kg were significantly more effective than placebo in reducing the incidence of emesis prior to, following discharge, and during the first 24 postoperative hours (p < 0.001). There were no significant differences in the occurrence of emesis between the groups receiving ondansetron 0.05 mg/kg, 0.1 mg/kg, and 0.15 mg/kg. The addition of oral metoclopramide 0.15 mg/kg had no effect on the incidence of emesis in the ondansetron or placebo study groups.ConclusionsOndansetron is an effective medication for the treatment and prevention of postoperative nausea and vomiting, and a dose of ondansetron 0.05 mg/kg is as effective as 0.1 mg/kg and 0.15 mg/kg. Metoclopramide 0.15 mg/kg has no effect on the incidence of postoperative nausea and vomiting.
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