Efficacy of Intravenous Naproksen Sodium+Codein and Paracetamol+Codein on Postoperative Pain on Postoperative Pain

Phase 4

• Conditions: Postoperative Pain, PCA Contramal Consumption
• Interventions: Drug: naproxen sodium codein; Drug: paracetamol codein; Drug: Placebo

• Registration Number: NCT02252614
• Lead Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

Brief Summary

Comparition the analgesic effects of intravenous naproksen sodyum+codein with that of paracetamol+codein on postoperative pain and contramal consumption during the first 24 hour after a lumbar disk surgery.

Detailed Description

Patients were treated using patient-controlled analgesia with contramal for 24 hours after a lumbar disk surgery and randomized to receive IV naproksen sodium+codein, paracetamol+codein or isotonic saline (placebo).

The primary endpoint was pain intensity measured by the visual analogue scale, and secondary endpoints were contramal consumption and related side effects.

Study Timeline

• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-09-29
• Last Update Submitted: 2014-09-29
• Study First Posted: 2014-09-30
• Last Update Posted: 2014-09-30
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• American Society of Anesthesiologists 1 or 2 status patients scheduled for elective lumbar disk surgery under general anesthesia

Exclusion Criteria

• Patients, known allergies to any of the drugs used in this study
• eptic ulcer disease, hepatic and renal dysfunction, emergency surgery, or inability to provide informed consent (eg, mental disorders)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naproxen sodium codein	naproxen sodium codein	Preoperative Naproxen sodium codein administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.
Paracetamol codein	paracetamol codein	Preoperative paracetamol codein administrered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.
Placebo tablet	Placebo	Preoperative placebo tablet administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.

Primary Outcome Measures

Name	Time	Method
Pain intensity, contramal consumption	Postoperative 24 hour

Secondary Outcome Measures

Name	Time	Method
side effects, nausa, vomiting	postoperative 24 hour