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

This study has been terminated.

( DSMB review at 50% recruitment, further recruitment unlikely to change result )

First Received: June 15, 2006 Last Updated: April 13, 2009 History of Changes

Sponsor:	Planned Parenthood League of Massachusetts
Collaborator:	An anonymous Foundation.
Information provided by:	Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier:	NCT00337792

Purpose

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.

Condition	Intervention
Undesired Pregnancy	Drug: oxycodone + lorazepam versus fentanyl + midazolam

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Midazolam Oxycodone Fentanyl Lorazepam

U.S. FDA Resources

Further study details as provided by Planned Parenthood League of Massachusetts:

Primary Outcome Measures:

Pain scale

Secondary Outcome Measures:

Measures of satisfaction, side effects, recovery time

Enrollment:	132
Study Start Date:	June 2006
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337792

Locations

United States, Massachusetts
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Planned Parenthood League of Massachusetts

An anonymous Foundation.

Investigators

Principal Investigator:

Jane Doe

Planned Parenthood League of Massachusetts

More Information

No publications provided by Planned Parenthood League of Massachusetts

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Allen RH, Fitzmaurice G, Lifford KL, Lasic M, Goldberg AB. Oral compared with intravenous sedation for first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2009 Feb;113(2 Pt 1):276-83.

Responsible Party:	Planned Parenthood League of MA ( Jane Doe )
Study ID Numbers:	2005-P-002284/1
Study First Received:	June 15, 2006
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00337792 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 27, 2009