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Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions
Sponsor: University of Rochester
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
2026-06-29
Completion Date
2027-02
Last Updated
2026-08-21
Healthy Volunteers
No
Interventions
Diphenhydramine
Diphenhydramine 50 mg administered intravenously once prior to the procedure.
Placebo
Matching placebo composed of normal saline administered intravenously once prior to the procedure.
Locations (1)
Gender Wellness OB/GYN
Rochester, New York, United States