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

Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02252614
Collaborator
(none)
75
Enrollment
3
Arms
3
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: naproxen sodium codein
  • Drug: paracetamol codein
  • Drug: Placebo
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Intravenous Naproksen Sodium+Codein and Paracetamol+Codein on Postoperative Pain and Contramal Consumption After a Lumbar Disk Surgery
Study Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2014
Anticipated Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Naproxen sodium codein

Preoperative Naproxen sodium codein administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.

Drug: naproxen sodium codein
Pain intensity, contramal consumption
Other Names:
  • Apranax plus

    		•
    Experimental: Paracetamol codein

    Preoperative paracetamol codein administrered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.

    Drug: paracetamol codein
    Pain intensity, contramal consumption
    Other Names:
  • Geralgine K tablet

    		•
    Placebo Comparator: Placebo tablet

    Preoperative placebo tablet administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.

    Drug: Placebo
    Pain intensity, contramal consumption
    Other Names:
  • Placebo tablet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain intensity, contramal consumption [Postoperative 24 hour]

    Secondary Outcome Measures

    1. side effects, nausa, vomiting [postoperative 24 hour]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Diskapi Yildirim Beyazit Education and Research Hospital

    Investigators

    • Principal Investigator: Reyhan Polat, MD, Diskapi YBERH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Reyhan Polat, Medical Doctor, Diskapi Yildirim Beyazit Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT02252614
    Other Study ID Numbers:
    • DiskapiYBERH
    First Posted:
    Sep 30, 2014
    Last Update Posted:
    Sep 30, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Reyhan Polat, Medical Doctor, Diskapi Yildirim Beyazit Education and Research Hospital
    naproxen sodium+codein, paracetamol+codein,lumbar disc surgery
    Additional relevant MeSH terms:
    Pain, Postoperative
    Acetaminophen
    Naproxen
    Codeine

    Study Results

    No Results Posted as of Sep 30, 2014