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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 )
Study NCT00337792   Information provided by Planned Parenthood League of Massachusetts
First Received: June 15, 2006   Last Updated: April 13, 2009   History of Changes

June 15, 2006
April 13, 2009
June 2006
July 2007   (final data collection date for primary outcome measure)
Pain scale
Same as current
Complete list of historical versions of study NCT00337792 on ClinicalTrials.gov Archive Site
Measures of satisfaction, side effects, recovery time
Same as current
 
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

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.

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.

 
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Undesired Pregnancy
Drug: oxycodone + lorazepam versus fentanyl + midazolam
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
132
July 2007
July 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00337792
Jane Doe, Planned Parenthood League of MA
2005-P-002284/1
Planned Parenthood League of Massachusetts
An anonymous Foundation.
Principal Investigator: Jane Doe Planned Parenthood League of Massachusetts
Planned Parenthood League of Massachusetts
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP