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

Not Applicable

Terminated

• Conditions: Undesired Pregnancy

• Registration Number: NCT00337792
• Lead Sponsor: Planned Parenthood League of Massachusetts

Brief 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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-15
• Study First Submitted QC: 2006-06-15
• Study First Posted: 2006-06-16
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 132

Inclusion Criteria

• Age 18 or older.
• Undesired pregnancy between 6 0/7-12 6/7 weeks gestation.
• Has already signed consent for pregnancy termination.
• Eligible for IV sedation per clinic protocol.

Exclusion Criteria

• Under 120 lbs.
• Allergies to any of the drugs being studied.
• Chronic narcotics, barbiturates or benzodiazepine use within the past year.
• History of IV drug use within the last year.
• Inability to give informed consent.
• Does not speak English or Spanish and does not have translator for all study procedures
• Previously participated in study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pain scale

Secondary Outcome Measures

Name	Time	Method
Measures of satisfaction, side effects, recovery time

Trial Locations

Locations (1)

Planned Parenthood League of Massachusetts; 🇺🇸 Boston, Massachusetts, United States