drugset / Trial / NCT01812057

Dexamethasone for Post-cesarean Delivery Pain

NCT01812057 ↗

Phase 4 Completed 53 enrolled Duke University
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to compare post-cesarean section consumption of pain medication between two groups of patients undergoing scheduled cesarean section at term gestation who receive a single-dose of intraoperative steroid (dexamethasone 8 milligrams) versus placebo at 24 hours after surgery. The hypothesis is that a single perioperative dose of dexamethasone 8 mg will significantly reduce postoperative opioid consumption at 24 h in women having cesarean delivery under spinal anesthesia.

Timeline

Start
2012-12
Primary completion
2016-05-27
Completion
2016-09-21

Outcome

Missed primary endpoint

registry analysis (superiority test); Dexamethasone vs Placebo; p = 0.740; Wilcoxon (Mann-Whitney) NCT01812057 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 8 mg Intravenous

Indications