drugset / Trial / NCT04060771

Post-Operative Nausea and Vomiting in Children Submitted to Strabismus Surgery

NCT04060771

Phase 3 Unknown 80 enrolled Fluminense Federal University
RandomizedParallel-groupDouble-blindPrevention

Summary

Background: Postoperative nausea and vomiting (PONV) is one of the main causes of patient and family dissatisfaction, which may delay the onset of oral intake and postpone discharge. In pediatric patients, the incidence of PONV is high, and in some studies it can reach values of 70%. Strabismus surgery is considered an independent risk factor for PONV. Palonosetron is a second generation antiemetic drug, 5-hydroxytryptamine receptor antagonist, with a long half-life, which allows single dose administration and has been shown to be safe and effective in the treatment of chemotherapy induced nausea and vomiting, and has been used with satisfactory results in the prophylaxis of PONV in adult and pediatric patients. Studies involving palonosetron are still scarce.

Timeline

Start
2018-08-01
Primary completion
2019-11-01
Completion
2020-07-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 0.2 mg/kg Intravenous
Subject Palonosetron Other / unclassified 1 ug/kg Intravenous

Indications