drugset / Trial / NCT02793843

Ondansetron vs Ondansetron Plus Dexamethasone for Relieving Intrathecal Morphine Side Effects After C-section

NCT02793843

Completed 194 enrolled Makassed General Hospital
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Background: Common adverse side effects related to the use of neuraxial opioids in the obstetric population include nausea, vomiting, and pruritus. Serotonin (5-HT3) receptor antagonists, in particular ondansetron, have been identified as possible antipruritic agents. It was reported that dexamethasone plus ondansetron is more effective than ondansetron for prevention of postoperative nausea and vomiting but no additional effect on treating pruritus. Objectives: The purpose of this study is to compare the effect of prophylactic ondansetron versus ondansetron plus dexamethasone after cesarean section on pruritus and postoperative nausea and vomiting (PONV). Methods: A prospective randomized double blind study that will be conducted between June 2016 and June 2017. Patients will be randomly allocated into two groups. The first group will receive 4 mg intravenous (IV) ondansetron while the other group will receive 4 mg IV ondansetron plus 8 mg dexamethasone.

Timeline

Start
2016-06
Primary completion
2017-06-15
Completion
2017-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 8 mg Intravenous
Subject Ondansetron Other / unclassified 4 mg Intravenous

Indications

No indication recorded.