Naproxen Codeine in Arthroscopic Surgery

September 26, 2013 updated by: CAGLA BALI,MD, Baskent University

Comparison of Post-operative Analgesic Effects of Naproxen Sodium and Naproxen Sodium-codeine Phosphate Administered Preemptively for Arthroscopic Meniscus Surgery

In this study, the aim is to compare the efficacy of single dose naproxen sodium and combination of naproxen sodium-codeine phosphate on post-operative pain in adult patients undergoing arthroscopic menisectomy.Pre-emptive oral naproxen-codeine may be safely and more advantageous than naproxen alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients receiving preemptive oral naproxen sodium (Group N) or naproxen sodium-codeine phosphate (Group NC) were assigned in 2 groups.Preoperatively, drugs were given orally by a nurse unaware of the study to both groups within 60 minutes before surgery. Hemodynamic datas, possible side effects, pain and sedation levels of patients were recorded. Patient's pain and sedation levels were statistically assessed.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 4

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

  • Turkey
      • Adana, Turkey, 01250
        • Baskent University School of Medicine Adana Teaching and Research Hospital

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing arthroscopic meniscectomy were included in the study.

Exclusion Criteria:

  • ≤ 18 years of age
  • hypersensitivity to non-steroidal anti-inflammatory drugs and codeine,
  • history of peptic ulcer, gastritis, upper gastrointestinal bleeding
  • coagulation disorder
  • serious hepatic and renal impairment
  • pregnancy
  • long-term NSAID and opioid use

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Naproxen sodium (Group N)
Group N received naproxen sodium 550 mg 60 minutes before surgery.
Drug: Group N:Naproxen sodium
drug will be given 60 minutes before surgery
Other Names:
  • Apranax fort tb, Abdi Ibrahim Ilaç,Turkiye
Active Comparator: Group Naproxen sodium codeine phosphate (Group NC)
Group NC received naproxen sodium 550 mg+30 mg codeine 60 minutes before surgery.
Drug: Group NC :naproxen sodium codeine phosphate
drug will be given 60 minutes before surgery
Other Names:
  • Apranax plus tb, Abdi Ibrahim Ilac, Turkey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores as measured by Visual Analogue Scale were significantly lower in Group Naproxen codeine (group NC) at all time points compared to Group Naproxen (group N) in 61 patients who underwent arthroscopic meniscus surgery.
Time Frame: postoperative 18 hours
patients will be followed postoperatively 18 hours for pain levels
postoperative 18 hours

Collaborators and Investigators

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

Sponsor

Baskent University

Investigators

  • Study Director: Anis Aribogan, Prof.,MD, Başkent University School of Medicine

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

January 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

September 26, 2013

First Posted (Estimate)

September 30, 2013

Study Record Updates

Last Update Posted (Estimate)

September 30, 2013

Last Update Submitted That Met QC Criteria

September 26, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA12/268

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.

Clinical Trials on Arthroscopic Meniscus Surgery

Clinical Trials on Group N:Naproxen sodium

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe