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Naproxen Versus Tramadol for Post Cesarean Pain Control

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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

Brief Summary:
Oral naproxen might be more efficacious for post-cesarean pain-control and have better side-effects profile than oral tramadol.

Condition or disease Intervention/treatment Phase
Pain Cesarean Section Drug: Naproxen Tramadol Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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
Study Start Date : August 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Pain Score

Secondary Outcome Measures :
  1. Side effects


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

Inclusion Criteria:

  • all patients after cesarean section

Exclusion Criteria:

  • emergent CS
  • hypersensitivity to drug
  • drug abuse

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

Responsible Party: Ron Gonen
ClinicalTrials.gov Identifier: NCT01165814     History of Changes
Other Study ID Numbers: TRAMNAP
First Posted: July 20, 2010    Key Record Dates
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