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NOT YET RECRUITING
NCT07542730
PHASE4

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

Sponsor: University of Rochester

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2026-05

Completion Date

2027-02

Last Updated

2026-04-21

Healthy Volunteers

No

Interventions

DRUG

Diphenhydramine

Diphenhydramine 50 mg administered intravenously once prior to the procedure.

DRUG

Placebo

Matching placebo composed of normal saline administered intravenously once prior to the procedure.