RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: University of Rochester • ClinicalTrials.gov ID: NCT07542730

Registry updated: 2026-08-21

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Description

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.

Interventions

Diphenhydramine (Drug)
Diphenhydramine 50 mg administered intravenously once prior to the procedure.
Placebo (Drug)
Matching placebo composed of normal saline administered intravenously once prior to the procedure.

Eligibility criteria

Inclusion Criteria: * Adults age 18 years and older * Desire procedural abortion with moderate sedation * Gestational age less than or equal to 13 weeks * Intrauterine pregnancy or pregnancy of unknown location * Body mass index less than or equal to 40 Exclusion Criteria: * Desire medical abortion or desire to continue pregnancy * Gestational age greater than 13 weeks * Body mass index greater than 40 * Age younger than 18 years * Confirmed ectopic pregnancy * Medical condition that is a contraindication to moderate sedation as determined by the treating clinician

Conditions

Pain Abortion Anxiety

Locations

Gender Wellness OB/GYN — Rochester, New York, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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