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

NCT07542730 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Placebo

Matching placebo composed of normal saline administered intravenously once prior to the procedure.

DRUG

Diphenhydramine

Diphenhydramine 50 mg administered intravenously once prior to the procedure.

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-02-28
Completion
2027-02-28
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07542730 on ClinicalTrials.gov