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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
2026-05
Completion Date
2027-02
Last Updated
2026-04-21
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.