RecruitingPhase 4NCT07542730

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


Sponsor

University of Rochester

Enrollment

98 participants

Start Date

Jun 29, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Diphenhydramine and a drug called Placebo for people with abortion, anxiety, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDiphenhydramine

Diphenhydramine 50 mg administered intravenously once prior to the procedure.

DRUGPlacebo

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


Locations(1)

Gender Wellness OB/GYN

Rochester, New York, United States

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NCT07542730


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