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)
Sponsor:
Collaborator:
Anonymous
Information provided by:
Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier:
NCT00337792
First received: June 15, 2006
Last updated: April 13, 2009
Last verified: April 2009
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 01, 2014