Comparing the Effectiveness of Oral Versus Intravenous Pain Medicine for Suction Curettage (D&C)

Undesired Pregnancy Clinical Trial

Official title: A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion

Status Terminated

Clinical Trial Summary

The main objective of this study is to determine the equivalency of oral conscious sedation and intravenous conscious sedation for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation for pain control. Additional objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.

Clinical Trial Description

The main objective of this study is to determine the equivalency of oral conscious sedation (oxycodone 10mg PO plus lorazepam 1mg SL) and intravenous conscious sedation (fentanyl 100 µg plus midazolam 2mg) for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation as defined by ± 1 point on a 21-point pain scale. Subsidiary objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Undesired Pregnancy

• NCT number: NCT00337792
• Study type: Interventional
• Source: Planned Parenthood League of Massachusetts
• Status: Terminated
• Phase: N/A
• Start date: June 2006
• Completion date: July 2007