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Trial record 36 of 74 for:    Codeine AND Acetaminophen

Postoperative Analgesia in Laminectomy ((PAL))

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ClinicalTrials.gov Identifier: NCT02255955
Recruitment Status : Unknown
Verified December 2014 by Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 3, 2014
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital

Brief Summary:
Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a lumbar disk surgery.

Condition or disease Intervention/treatment Phase
Postoperative Pain Postoperative Laminectomy Pain Drug: 550 mg naproxen sodium and 30mg codeine Drug: 300 mg paracetamol and 30 mg codeine Drug: placebo tablet Phase 4

Detailed Description:
Compare the analgesic effects of naproxen sodium codeine paracetamol codeine and placebo on postoperative pain intensity measured by the visual analogue scale, and evaluated tramadol 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, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Naproxen Sodium + Codeine, and Paracetamol+ Codeine on Postoperative Laminectomy Pain
Study Start Date : October 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
Experimental: 550 mg naproxen sodium and 30mg codeine
Preoperatively patients received oral naproxen sodium codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
Drug: 550 mg naproxen sodium and 30mg codeine
Postoperative contramal consumption, pain intensity, side effects
Other Name: Apranax plus

Active Comparator: 300 mg paracetamol and 30 mg codeine
Preoperatively patients received oral paracetamol codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
Drug: 300 mg paracetamol and 30 mg codeine
Postoperative contramal consumption, pain intensity, side effects
Other Name: geralgine K

Placebo Comparator: Placebo
Preoperatively patients received oral placebo tablet, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
Drug: placebo tablet
Postoperative contramal consumption, pain intensity, side effects




Primary Outcome Measures :
  1. Contramal consumption [ Time Frame: Postoperative 24 hour ]
    To assess contramal consumption


Secondary Outcome Measures :
  1. Side effects [ Time Frame: postoperative 24 hour ]
    nausea and vomiting

  2. Pain intensity [ Time Frame: postoperative 24 hour ]
    To assess postoperative pain intensity by visual analog scale



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Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) 1 or 2 status patients scheduled for an elective lumbar disc surgery

Exclusion Criteria:

  • were known allergies to any of the drugs used in this study
  • peptic ulcer disease
  • hepatic and renal dysfunction,
  • emergency surgery
  • inability to provide informed consent

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): NCT02255955


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 Netherlands: Ministry of Health, Welfare and Sports

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Responsible Party: Reyhan Polat, Medical Doctor, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02255955     History of Changes
Other Study ID Numbers: Pstoperative pain
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Keywords provided by Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital:
naproxen sodium codeine
paracetamol codeine
disk surgery
Additional relevant MeSH terms:
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Acetaminophen
Codeine
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Naproxen
Tramadol
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