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Naproxen Versus Tramadol for Post Cesarean Pain Control

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01165814
First Posted: July 20, 2010
Last Update Posted: July 20, 2010
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.
Information provided by:
Bnai Zion Medical Center
  Purpose
Oral naproxen might be more efficacious for post-cesarean pain-control and have better side-effects profile than oral tramadol.

Condition Intervention
Pain Cesarean Section Drug: Naproxen Tramadol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Naproxen Versus Oral Tramadol for Analgesia After Cesarean Delivery - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • Pain Score

Secondary Outcome Measures:
  • Side effects

Enrollment: 120
Study Start Date: August 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tramadol at fixed intervals Drug: Naproxen Tramadol
Active Comparator: Tramadol on request Drug: Naproxen Tramadol
Active Comparator: Naproxen at fixed intervals Drug: Naproxen Tramadol
Active Comparator: Naproxen on request Drug: Naproxen Tramadol

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • all patients after cesarean section

Exclusion Criteria:

  • emergent CS
  • hypersensitivity to drug
  • drug abuse
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01165814


Locations
Israel
Bnai Zion Medical Center
Haifa, Israel
Sponsors and Collaborators
Bnai Zion Medical Center
  More Information

Responsible Party: Ron Gonen
ClinicalTrials.gov Identifier: NCT01165814     History of Changes
Other Study ID Numbers: TRAMNAP
First Submitted: July 18, 2010
First Posted: July 20, 2010
Last Update Posted: July 20, 2010
Last Verified: July 2010

Keywords provided by Bnai Zion Medical Center:
Pain control after cesarean section

Additional relevant MeSH terms:
Tramadol
Naproxen
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action