drugset / Trial / NCT07542730
Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions
RandomizedParallel-groupQuadruple-blindSupportive care
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.
Timeline
- Start
- 2026-05
- Primary completion
- 2027-02
- Completion
- 2027-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diphenhydramine | Unknown | 50 mg | Intravenous |