Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diphenhydramine, Placebo.
- Who it may be relevant to
- Registry conditions: Pain, Abortion, Anxiety. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Surgical abortion is commonly associated with pain and anxiety despite use of local anesthesia and moderate sedation. This study will evaluate the efficacy of intravenous diphenhydramine as an adjunct to a standard moderate sedation regimen for participants undergoing first trimester procedural abortion.
This is a single center, double blind, randomized, placebo controlled trial conducted at the University of Rochester Family Planning Clinic and Strong Memorial Hospital. Participants undergoing first trimester uterine aspiration at less than or equal to 13 weeks gestation will be randomized in a 1 to 1 ratio using a computer generated block randomization scheme to receive either intravenous diphenhydramine 50 mg or matching placebo, in addition to standard moderate sedation with midazolam and fentanyl. Participants, clinical staff, and outcome assessors will remain blinded to treatment assignment.
Pain will be assessed using a 100 mm Visual Analog Scale at baseline, during speculum placement, paracervical block, cervical dilation, uterine aspiration, 10 minutes after the procedure, and 1 hour after the procedure. Sedation depth during uterine aspiration will be assessed using the Modified Observer's Assessment of Alertness Sedation scale. Additional outcomes include total sedative medication dose, time to readiness for discharge, and sedation related adverse events.
Interventions
- Drug Diphenhydramine
Diphenhydramine 50 mg administered intravenously once prior to the procedure. - Drug Placebo
Matching placebo composed of normal saline administered intravenously once prior to the procedure.
Primary outcome measures
- Participant-Reported Pain During Uterine Aspiration [Time frame: During the procedure, at the time of uterine aspiration]
Secondary outcome measures (8)
- Sedation Depth During Uterine Aspiration [Time frame: During the procedure, at the time of uterine aspiration]
- Participant-Reported Pain at Speculum Placement [Time frame: During the procedure, at the time of speculum placement]
- Participant-Reported Pain at Paracervical Block [Time frame: During the procedure, at the time of Paracervical Block]
- Participant-Reported Pain at Cervical Dilation [Time frame: During the procedure, at the time of Cervical Dilation]
- Participant-Reported Pain 10 Minutes After Procedure Completion [Time frame: 10 minutes after completion of the procedure]
- Participant-Reported Pain 1 Hour After Procedure Completion [Time frame: 1 hour after completion of the procedure]
- Time to Readiness for Discharge [Time frame: From completion of the procedure until discharge readiness, up to approximately 2 hours]
- Incidence of Sedation-Related Adverse Events [Time frame: From administration of study medication through discharge on the day of procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07542730 · STUDY00011436