Naproxen Versus Tramadol for Post Cesarean Pain Control

July 19, 2010 updated by: Bnai Zion Medical Center

Oral Naproxen Versus Oral Tramadol for Analgesia After Cesarean Delivery - A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Bnai Zion Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • all patients after cesarean section

Exclusion Criteria:

  • emergent CS
  • hypersensitivity to drug
  • drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain Score

Secondary Outcome Measures

Outcome Measure
Side effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bnai Zion Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

July 18, 2010

First Submitted That Met QC Criteria

July 19, 2010

First Posted (Estimate)

July 20, 2010

Study Record Updates

Last Update Posted (Estimate)

July 20, 2010

Last Update Submitted That Met QC Criteria

July 19, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRAMNAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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