Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions
NCT07542730
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
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
Conditions3
Interventions1
Locations1 site
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NCT07542730