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Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions
NCT07542730Phase 4
Key facts
- Status
- Recruiting
- Start
- Jun 2026
- Primary completion
- Feb 2027
- Countries
- 1
- Sponsor
- University of Rochester
- Modality
- Small Molecules
- Drugs
- diphenhydramine
- Conditions
- painanxiety disorder
01
Overview
Phase 4, randomised, double-blind trial in pain and anxiety disorder comparing Diphenhydramine plus standard moderate sedation with Placebo plus standard moderate sedation (2 arms). Primary endpoint: Participant-Reported Pain During Uterine Aspiration. Started Jun 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Diphenhydramine plus standard moderate sedation
Intravenous diphenhydramine 50 mg + midazolam + fentanyl
Placebo plus standard moderate sedation
Intravenous placebo + midazolam + fentanyl
03
Who it enrols
Adults with a gestational age <= 13 weeks desiring procedural abortion with moderate sedation, BMI <= 40, excluding those with ectopic pregnancy or contraindications to moderate sedation.
04
Endpoints
Primary
Participant-Reported Pain During Uterine Aspiration
Secondary
Sedation Depth During Uterine Aspiration
Participant-Reported Pain at Speculum Placement
Participant-Reported Pain at Paracervical Block
Participant-Reported Pain at Cervical Dilation
Participant-Reported Pain 10 Minutes After Procedure Completion
Participant-Reported Pain 1 Hour After Procedure Completion
Time to Readiness for Discharge
Incidence of Sedation-Related Adverse Events
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