Trial intelligence / Profile preview

Naproxen/Codeine vs Paracetamol/Codeine for Postoperative Laminectomy Pain

NCT02255955Phase 4

Key facts

Status
Unknown
Start
Oct 2014
Primary completion
Dec 2014
Sponsor
Dışkapı Yıldırım Beyazıt Training and Research Hospital
Modality
Implantable Devices, Transdermal Patches, Inhalation Devices
Conditions
postoperative pain
01

Overview

Phase 4, randomised trial of Naproxen sodium + codeine in postoperative pain (3 arms), sponsored by Dışkapı Yıldırım Beyazıt Training and Research Hospital. Primary endpoint: Tramadol (Contramal) consumption at 24 hours. Status: unknown.

02

Design

3 arms
Study design
Randomized
  • Naproxen + Codeine

    Oral naproxen sodium 550 mg + codeine 30 mg preoperatively

  • Paracetamol + Codeine

    Oral paracetamol 300 mg + codeine 30 mg preoperatively

  • Placebo

    Oral placebo preoperatively

03

Who it enrols

ASA 1 or 2 patients scheduled for elective lumbar disc surgery. Excludes allergies, peptic ulcer, hepatic/renal dysfunction, emergency surgery.

04

Endpoints

Primary

  • Tramadol (Contramal) consumption

Secondary

  • Related side effects

  • Pain intensity measured by VAS

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