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

RecruitingPhase 4

Sponsor: University of Rochester

Conditions: Pain, Abortion, Anxiety

Interventions: Diphenhydramine, Placebo

Countries: United States

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Rochester, New York, United States