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A Double Blinded, Placebo-controlled Randomized Control Trial Comparing Intravenous Moderate Sedation and Oral/Sublingual Analgesia/Anxiolysis for First Trimester Surgical Abortions

NCT01011634 Phase 4 TERMINATED Results posted

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.

Details

Lead sponsorUniversity of California, San Francisco
PhasePhase 4
StatusTERMINATED
Enrolment18
Start date2007-05
Completion2008-11

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Countries

United States