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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00337792
• Other study ID #: 2005-P-002284/1
• Status: Terminated
• Phase: N/A
• First received: June 15, 2006
• Last updated: March 16, 2016
• Start date: June 2006
• Est. completion date: July 2007

Study information

• Verified date: March 2016
• Source: Planned Parenthood League of Massachusetts
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 132
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Drug:
• oxycodone + lorazepam versus fentanyl + midazolam

Locations

Country	Name	City	State
United States	Planned Parenthood League of Massachusetts	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Planned Parenthood League of Massachusetts

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scale
Secondary	Measures of satisfaction, side effects, recovery time