Trial Comparing Intravenous and Oral Moderate Sedation for First Trimester Surgical Abortions

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

In the United States, the majority of first-trimester surgical abortions are performed in outpatient clinics that utilize a wide variety of oral and intravenous regimens for pain control. The specific aim of this study is to evaluate the equivalency of intravenous moderate sedation (fentanyl 100 mcg and midazolam 2 mg) versus oral analgesia/anxiolysis (lorazepam 2 mg sublingual, hydrocodone/acetaminophen 5/500 mg, and ibuprofen 800 mg) for first-trimester surgical abortions. The investigators hypothesize that oral moderate sedation and intravenous moderate sedation will be equivalent in controlling pain as measured by a difference of +/- 10 on a 100-point (range 0-100) visual analog pain scale.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco

Criteria

Inclusion Criteria:

1. Intrauterine pregnancy <12 weeks gestation (as confirmed by ultrasound)

2. Ability to undergo outpatient abortion without an anesthesiologist

3. Age ≥ 16 years old

4. Informed consent prior to participation in study

5. English or Spanish language capacity (or staff or professional translator available for all study procedures)

Exclusion Criteria:

1. Possible ectopic pregnancy

2. Known allergy to study medications or misoprostol

3. Current unstable psychiatric disorder

4. Current alcohol/drug/narcotic/benzodiazepine/barbituate dependence within the previous 2 months

5. Weight < 50 kg