drugset / Trial / NCT01011634
Trial Comparing Intravenous and Oral Moderate Sedation for First Trimester Surgical Abortions
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |