drugset / Trial / NCT01011634

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

NCT01011634

Phase 4 Terminated 18 enrolled University of California, San Francisco
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2007-05
Primary completion
2008-11
Completion
2008-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 500 mg Oral
Comparator Fentanyl Other / unclassified 100 ug Intravenous
Comparator Hydrocodone Unknown 5 mg Oral
Comparator Ibuprofen Small molecule 800 mg Oral
Comparator Lorazepam Small molecule 2 mg Other
Comparator Midazolam Small molecule 2 mg Intravenous