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

NCT07542730 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY00011436
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Participant-Reported Pain During Uterine Aspiration

  Pain intensity will be measured using a 100 mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 mm, where 0 represents "no pain" and 100 represents "worst pain imaginable." Higher scores indicate greater pain intensity. This outcome measures the participant's perceived pain during uterine aspiration.

  During the procedure, at the time of uterine aspiration

Secondary Outcomes (8)

• Sedation Depth During Uterine Aspiration

  During the procedure, at the time of uterine aspiration

• Participant-Reported Pain at Speculum Placement

  During the procedure, at the time of speculum placement

• Participant-Reported Pain at Paracervical Block

  During the procedure, at the time of Paracervical Block

• Participant-Reported Pain at Cervical Dilation

  During the procedure, at the time of Cervical Dilation

• Participant-Reported Pain 10 Minutes After Procedure Completion

  10 minutes after completion of the procedure

Study Arms (2)

Diphenhydramine plus standard moderate sedation

EXPERIMENTAL

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.

Drug: Diphenhydramine

Placebo plus standard moderate sedation

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Diphenhydramine DRUG

Diphenhydramine 50 mg administered intravenously once prior to the procedure.

Also known as: Bendaryl

Diphenhydramine plus standard moderate sedation

Placebo DRUG

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

Placebo plus standard moderate sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Diphenhydramine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Sarah Cavegila, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Department of Obstetrics and Gynecology (SMD)

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 21, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04