drugset / Trial / NCT07542730

Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions

NCT07542730

Phase 4 Not yet recruiting 98 enrolled University of Rochester
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

This single center, double blind, randomized controlled trial will evaluate whether adding intravenous diphenhydramine to a standard moderate sedation regimen improves pain control during first trimester procedural abortion. Participants undergoing uterine aspiration at less than 13 weeks gestation will be randomized 1 to 1 to receive standard moderate sedation with midazolam and fentanyl plus either diphenhydramine 50 mg intravenously or matching placebo. The primary outcome is participant reported pain during uterine aspiration measured by a 100 mm Visual Analog Scale.

Timeline

Start
2026-05
Primary completion
2027-02
Completion
2027-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Diphenhydramine Unknown 50 mg Intravenous

Indications