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Naproxen Versus Tramadol for Post Cesarean Pain Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01165814
Recruitment Status : Completed
First Posted : July 20, 2010
Last Update Posted : July 20, 2010
Sponsor:
Information provided by:
Bnai Zion Medical Center

Tracking Information
First Submitted Date  ICMJE July 18, 2010
First Posted Date  ICMJE July 20, 2010
Last Update Posted Date July 20, 2010
Study Start Date  ICMJE August 2006
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2010)
Pain Score
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2010)
Side effects
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Naproxen Versus Tramadol for Post Cesarean Pain Control
Official Title  ICMJE Oral Naproxen Versus Oral Tramadol for Analgesia After Cesarean Delivery - A Randomized Controlled Trial
Brief Summary Oral naproxen might be more efficacious for post-cesarean pain-control and have better side-effects profile than oral tramadol.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Cesarean Section
Intervention  ICMJE Drug: Naproxen Tramadol
Study Arms  ICMJE
  • Active Comparator: Tramadol at fixed intervals
    Intervention: Drug: Naproxen Tramadol
  • Active Comparator: Tramadol on request
    Intervention: Drug: Naproxen Tramadol
  • Active Comparator: Naproxen at fixed intervals
    Intervention: Drug: Naproxen Tramadol
  • Active Comparator: Naproxen on request
    Intervention: Drug: Naproxen Tramadol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2010)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • all patients after cesarean section

Exclusion Criteria:

  • emergent CS
  • hypersensitivity to drug
  • drug abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01165814
Other Study ID Numbers  ICMJE TRAMNAP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ron Gonen
Study Sponsor  ICMJE Bnai Zion Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bnai Zion Medical Center
Verification Date July 2010

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