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

Postoperative Pain, PCA Contramal Consumption Clinical Trial

Official title:

Efficacy of Intravenous Naproksen Sodium+Codein and Paracetamol+Codein on Postoperative Pain and Contramal Consumption After a Lumbar Disk Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02252614
• Other study ID #: DiskapiYBERH
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 26, 2014
• Last updated: September 29, 2014
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: Reyhan Polat, MD
• Phone: +905326734310
• Email: reyhanp9[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain, PCA Contramal Consumption

Intervention

Drug:
• naproxen sodium codein
Pain intensity, contramal consumption
• paracetamol codein
Pain intensity, contramal consumption
• Placebo
Pain intensity, contramal consumption

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity, contramal consumption		Postoperative 24 hour	Yes
Secondary	side effects, nausa, vomiting		postoperative 24 hour	Yes