Recruiting

Midazolam & Fentanyl

Sponsor:

University of Rochester

Code:

NCT07542730

Conditions

Pain

Abortion

Anxiety

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diphenhydramine

Placebo

Study Details

Brief 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

Pain

Abortion

Anxiety

Study ID

NCT07542730

Start date

Jun 29, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Diphenhydramine plus standard moderate sedation

Participants receive intravenous diphenhydramine 50 mg prior to the procedure, in addition to standard moderate sedation with midazolam and fentanyl. Additional doses of midazolam and fentanyl may be administered during the procedure as clinically indicated.

placebo comparator: Placebo plus standard moderate sedation

Participants receive a matching intravenous placebo (normal saline) prior to the procedure, in addition to standard moderate sedation with midazolam and fentanyl. Additional doses of midazolam and fentanyl may be administered during the procedure as clinically indicated.

Interventions

Diphenhydramine

Diphenhydramine 50 mg administered intravenously once prior to the procedure.

Placebo

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

Primary outcome measure

  • Participant-Reported Pain During Uterine Aspiration [ Time Frame: During the procedure, at the time of uterine aspiration ]

Central Contacts and Locations

Central contacts

Sarah Cavegila, MPH

585-273-5734Sarah_Caveglia@URMC.Rochester.edu

Locations

Gender Wellness OB/GYN

Recruiting

Rochester, New York, United States, 14642

More Information

Sponsor

University of Rochester

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-08-21.