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Naproxen Codeine in Arthroscopic Surgery

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ClinicalTrials.gov Identifier: NCT01952652
Recruitment Status : Completed
First Posted : September 30, 2013
Last Update Posted : September 30, 2013
Sponsor:
Information provided by (Responsible Party):
CAGLA BALI,MD, Baskent University

Study Description
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Brief Summary:
In this study, the aim is to compare the efficacy of single dose naproxen sodium and combination of naproxen sodium-codeine phosphate on post-operative pain in adult patients undergoing arthroscopic menisectomy.Pre-emptive oral naproxen-codeine may be safely and more advantageous than naproxen alone.

Condition or disease Intervention/treatment Phase
Arthroscopic Meniscus Surgery Drug: Group N:Naproxen sodium Drug: Group NC :naproxen sodium codeine phosphate Phase 4

Detailed Description:
Patients receiving preemptive oral naproxen sodium (Group N) or naproxen sodium-codeine phosphate (Group NC) were assigned in 2 groups.Preoperatively, drugs were given orally by a nurse unaware of the study to both groups within 60 minutes before surgery. Hemodynamic datas, possible side effects, pain and sedation levels of patients were recorded. Patient's pain and sedation levels were statistically assessed.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Post-operative Analgesic Effects of Naproxen Sodium and Naproxen Sodium-codeine Phosphate Administered Preemptively for Arthroscopic Meniscus Surgery
Study Start Date : January 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group Naproxen sodium (Group N)
Group N received naproxen sodium 550 mg 60 minutes before surgery.
 Drug: Group N:Naproxen sodium
drug will be given 60 minutes before surgery
Other Name: Apranax fort tb, Abdi Ibrahim Ilaç,Turkiye
Active Comparator: Group Naproxen sodium codeine phosphate (Group NC)
Group NC received naproxen sodium 550 mg+30 mg codeine 60 minutes before surgery.
 Drug: Group NC :naproxen sodium codeine phosphate
drug will be given 60 minutes before surgery
Other Name: Apranax plus tb, Abdi Ibrahim Ilac, Turkey


Outcome Measures
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Primary Outcome Measures :
  1. Pain scores as measured by Visual Analogue Scale were significantly lower in Group Naproxen codeine (group NC) at all time points compared to Group Naproxen (group N) in 61 patients who underwent arthroscopic meniscus surgery. [ Time Frame: postoperative 18 hours ]
    patients will be followed postoperatively 18 hours for pain levels


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing arthroscopic meniscectomy were included in the study.

Exclusion Criteria:

  • ≤ 18 years of age
  • hypersensitivity to non-steroidal anti-inflammatory drugs and codeine,
  • history of peptic ulcer, gastritis, upper gastrointestinal bleeding
  • coagulation disorder
  • serious hepatic and renal impairment
  • pregnancy
  • long-term NSAID and opioid use
Contacts and Locations
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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): NCT01952652


Locations
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Turkey
Baskent University School of Medicine Adana Teaching and Research Hospital
Adana, Turkey, 01250
Sponsors and Collaborators
Baskent University
Investigators
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Study Director: Anis Aribogan, Prof.,MD Baskent University School of Medicine
More Information
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Responsible Party: CAGLA BALI,MD, MD,Anesthesiology and Reanimation, Baskent University
ClinicalTrials.gov Identifier: NCT01952652    
Other Study ID Numbers: KA12/268
First Posted: September 30, 2013    Key Record Dates
Last Update Posted: September 30, 2013
Last Verified: September 2013
Keywords provided by CAGLA BALI,MD, Baskent University:
Naproxen-codeine
preemptive analgesia
day case surgery
Additional relevant MeSH terms:
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Naproxen
Codeine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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