Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Rochester
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.
