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Published on: March 23, 2016
Ondansetron oral disintegrating tablets: acceptability and efficacy in children undergoing adenotonsillectomy
Ira Todd Cohen1, Denise Joffe, Kelly Hummer
1Department of Anesthesiology, Children's National Medical Center, 111 Michigan Ave. NW, Washington, DC 20010, USA. icohen@cnmc.org
Insights
Ondansetron oral disintegrating tablets (ODT) effectively reduced postoperative nausea and vomiting (PONV) in children undergoing adenotonsillectomy. While taste was acceptable, palatability was slightly lower than placebo, but efficacy was significant.
Area of Science:
- Anesthesiology
- Pediatric Surgery
- Pharmacology
Background:
- Postoperative nausea and vomiting (PONV) is a common complication in pediatric patients.
- Intravenous (IV) and oral ondansetron are effective but not always feasible.
- Ondansetron oral disintegrating tablets (ODT) offer an alternative delivery route.
Purpose of the Study:
- To evaluate the acceptability and efficacy of ondansetron ODT for PONV prevention in children.
- To compare ODT with placebo in a pediatric adenotonsillectomy population.
Main Methods:
- Double-blind, randomized, placebo-controlled study.
- 62 pediatric patients (5-11 years) received 4 mg ondansetron ODT or placebo preoperatively.
- Patient-reported acceptability (taste, sensation) and observer-assessed PONV, pain, and agitation.
Main Results:
- No significant differences in age, weight, recovery, pain, or agitation between groups.
- Approximately 90% found ODT palatable; ondansetron tablets were less palatable than placebo.
- Significantly lower incidence of vomiting in the ondansetron ODT group compared to placebo.
Conclusions:
- Ondansetron ODT is an acceptable and effective option for preventing PONV in pediatric adenotonsillectomy patients.
- ODT provides a viable alternative when IV or standard oral routes are unavailable.
- Further research may explore palatability improvements for pediatric formulations.
Abstract:
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.
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