Ondansetron oral disintegrating tablets: acceptability and efficacy in children undergoing adenotonsillectomy.

Postoperative nausea and vomiting (PONV), a major complication in children, is responsive to IV and oral ondansetron. Because these routes are not always available, we studied the acceptability and efficacy of ondansetron oral disintegrating tablets (ODT). In this double-blind, randomized, placebo-controlled study, 62 patients undergoing adenotonsillectomy, aged 5 to 11 years, preoperatively received ODT (4 mg) or placebo. Patients assessed the medication for taste and sensation. Anesthesia was induced with sevoflurane, maintained with desflurane, and supplemented with fentanyl 2.5 microg/kg and dexamethasone 0.5 mg/kg (maximum dose, 12 mg). An observer blinded to treatment evaluated patients for pain, agitation, and PONV. Postoperative treatment consisted of fentanyl 1 microg/kg for pain and agitation and metoclopramide 0.15 mg/kg (maximum dose, 10 mg) for PONV. There were no significant differences between study groups with regard to age, weight, recovery time, agitation, or pain. Approximately 90% of the subjects found the ODT to taste good. No subject rejected the study medication, but the ondansetron-containing tablets were found to be less palatable than the placebo. The incidence of vomiting was significantly less in the ondansetron-medicated group.

RCT Entities:   Population Interventions Outcomes