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

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ClinicalTrials.gov Identifier: NCT02252614
Recruitment Status : Unknown
Verified September 2014 by Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 30, 2014
Last Update Posted : September 30, 2014
Sponsor:
Information provided by (Responsible Party):
Reyhan Polat, 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.

Condition or disease Intervention/treatment Phase
Postoperative Pain, PCA Contramal Consumption 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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Placebo tablet




Primary Outcome Measures :
  1. Pain intensity, contramal consumption [ Time Frame: Postoperative 24 hour ]

Secondary Outcome Measures :
  1. side effects, nausa, vomiting [ Time Frame: postoperative 24 hour ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252614


Contacts
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Contact: Reyhan Polat, MD +905326734310 reyhanp9@gmail.com

Sponsors and Collaborators
Diskapi Yildirim Beyazit Education and Research Hospital
Investigators
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Principal Investigator: Reyhan Polat, MD Diskapi YBERH

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Responsible Party: Reyhan Polat, Medical Doctor, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02252614     History of Changes
Other Study ID Numbers: DiskapiYBERH
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014
Keywords provided by Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital:
naproxen sodium+codein, paracetamol+codein,lumbar disc surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Naproxen
Tramadol
Codeine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents