Trial Comparing Intravenous and Oral Moderate Sedation for First Trimester Surgical Abortions
Stopped early · Phase 4
Conditions studied: Undesired Intrauterine Pregnancy, First Trimester Pregnancy
In brief
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.
Key facts
- Study ID
- NCT01011634
- Run by
- University of California, San Francisco
- People needed
- 18
- Starts
- 2007-05-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2013-05-16
Who can join
Age: 16 and older, up to 55. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Intrauterine pregnancy <12 weeks gestation (as confirmed by ultrasound)
- Ability to undergo outpatient abortion without an anesthesiologist
- Age ≥ 16 years old
- Informed consent prior to participation in study
- English or Spanish language capacity (or staff or professional translator available for all study procedures)
You may not qualify if…
- Possible ectopic pregnancy
- Known allergy to study medications or misoprostol
- Current unstable psychiatric disorder
- Current alcohol/drug/narcotic/benzodiazepine/barbituate dependence within the previous 2 months
- Weight < 50 kg
Where it is running
- San Francisco General Hospital — San Francisco, California, United States
Full record on ClinicalTrials.gov
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