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Naproxen Versus Tramadol for Post Cesarean Pain Control

This study has been completed.
Sponsor:
Information provided by:
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT01165814
First received: July 18, 2010
Last updated: July 19, 2010
Last verified: July 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

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

Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • all patients after cesarean section

Exclusion Criteria:

  • emergent CS
  • hypersensitivity to drug
  • drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165814

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

No publications provided

Responsible Party: Ron Gonen
ClinicalTrials.gov Identifier: NCT01165814     History of Changes
Other Study ID Numbers: TRAMNAP
Study First Received: July 18, 2010
Last Updated: July 19, 2010
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013