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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Diphenhydramine
  • Placebo

Treatment groups

98 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators