NCT00337792

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Planned Parenthood League of Massachusetts · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Undesired Pregnancy

Interventions

Type	Name	Description
DRUG	oxycodone + lorazepam versus fentanyl + midazolam

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2006-06-16
• Last updated: 2016-03-18

Locations

1 site across 1 country: United States