University of Rochester
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.
Surgical abortion is commonly associated with pain and anxiety despite use of local anesthesia and moderate sedation. This study will evaluate the efficacy of intravenous diphenhydramine as an adjunct to a standard moderate sedation regimen for participants undergoing first trimester procedural abortion. This is a single center, double blind, randomized, placebo controlled trial conducted at the University of Rochester Family Planning Clinic and Strong Memorial Hospital. Participants undergoing first trimester uterine aspiration at less than or equal to 13 weeks gestation will be randomized i…
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
Diphenhydramine 50 mg administered intravenously once prior to the procedure.
Matching placebo composed of normal saline administered intravenously once prior to the procedure.
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