search
Back to results

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

Primary Purpose

Postoperative Pain, PCA Contramal Consumption

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
naproxen sodium codein
paracetamol codein
Placebo
Sponsored by
Diskapi Yildirim Beyazit Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain, PCA Contramal Consumption focused on measuring naproxen sodium+codein, paracetamol+codein,lumbar disc surgery

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Placebo Comparator

    Arm Label

    Naproxen sodium codein

    Paracetamol codein

    Placebo tablet

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    Pain intensity, contramal consumption

    Secondary Outcome Measures

    side effects, nausa, vomiting

    Full Information

    First Posted
    September 26, 2014
    Last Updated
    September 29, 2014
    Sponsor
    Diskapi Yildirim Beyazit Education and Research Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02252614
    Brief Title
    Efficacy of Intravenous Naproksen Sodium+Codein and Paracetamol+Codein on Postoperative Pain on Postoperative Pain
    Official Title
    Efficacy of Intravenous Naproksen Sodium+Codein and Paracetamol+Codein on Postoperative Pain and Contramal Consumption After a Lumbar Disk Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    December 2014 (Anticipated)
    Study Completion Date
    December 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Diskapi Yildirim Beyazit Education and Research Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain, PCA Contramal Consumption
    Keywords
    naproxen sodium+codein, paracetamol+codein,lumbar disc surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Naproxen sodium codein
    Arm Type
    Active Comparator
    Arm Description
    Preoperative Naproxen sodium codein administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.
    Arm Title
    Paracetamol codein
    Arm Type
    Experimental
    Arm Description
    Preoperative paracetamol codein administrered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.
    Arm Title
    Placebo tablet
    Arm Type
    Placebo Comparator
    Arm Description
    Preoperative placebo tablet administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.
    Intervention Type
    Drug
    Intervention Name(s)
    naproxen sodium codein
    Other Intervention Name(s)
    Apranax plus
    Intervention Description
    Pain intensity, contramal consumption
    Intervention Type
    Drug
    Intervention Name(s)
    paracetamol codein
    Other Intervention Name(s)
    Geralgine K tablet
    Intervention Description
    Pain intensity, contramal consumption
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Placebo tablet
    Intervention Description
    Pain intensity, contramal consumption
    Primary Outcome Measure Information:
    Title
    Pain intensity, contramal consumption
    Time Frame
    Postoperative 24 hour
    Secondary Outcome Measure Information:
    Title
    side effects, nausa, vomiting
    Time Frame
    postoperative 24 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Reyhan Polat, MD
    Phone
    +905326734310
    Email
    reyhanp9@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Reyhan Polat, MD
    Organizational Affiliation
    Diskapi YBERH
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs