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Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty (etoketo)

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ClinicalTrials.gov Identifier: NCT02568735
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Merja Kokki, Kuopio University Hospital

Brief Summary:
The main purpose of this study was to determine the plasma and central nervious system pharmacokinetics of dexketoprofen and etoricoxib. The secondary aim was to asses their effect on the concentrations of interleukin 6, prostaglandin E2 and other proinflammatory markers both in plasma and cerebrospinal fluid. Thirdly, the investigators aimed to evaluate their efficacy in postoperative pain treatment.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Dexketoprofen Drug: Etoricoxib Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Central Nervous Penetration of Dexketoprofen and Etoricoxib and Their Effect on Pain and Inflammatory Reaction in Patients Undergoing Hip Arthroplasty
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Etoricoxib
Etoricoxib 60mg if body weight≤ 60kg, 90mg if body weight 61-90kg and 120mg if body weight> 90kg by mouth
Drug: Etoricoxib
After total hip replacement surgery patient were given either etoricoxib or dexketoprofen

Active Comparator: Dexketoprofen
Dexketoprofen 0,5 mg/kg up to 50 mg intravenously
Drug: Dexketoprofen
After total hip replacement surgery patient were given either etoricoxib or dexketoprofen




Primary Outcome Measures :
  1. Cerebrospinal fluid concentration dexketoprofen and etoricoxib [ Time Frame: 0-24 hours ]
    Cerebrospinal fluid concentration of dexketoprofen and etoricoxib

  2. Plasma concentration dexketoprofen and etoricoxib [ Time Frame: 0-24 hours ]
    Plasma concentration dexketoprofen and etoricoxib


Secondary Outcome Measures :
  1. Pain [ Time Frame: 0-24 h ]
    Pain assessed with numeral rating scale



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • agreed to participate the study
  • American Society of Anesthesiologist s physical status classification 1-3
  • elective hip arthroplasty planned
  • no contraindications to the study drugs
  • no contraindication to lumbar puncture

Exclusion Criteria:

  • refused to participate the study
  • age less than 40 or over 75 years
  • Planned anesthesia method other than spinal anesthesia
  • contraindications to the study drugs
  • Contraindications to lumbar puncture
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Responsible Party: Merja Kokki, MD, PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT02568735    
Other Study ID Numbers: KUH30062008
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Merja Kokki, Kuopio University Hospital:
Dexketoprofen
Etoricoxib
hip arthroplasty
pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Etoricoxib
Dexketoprofen trometamol
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
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action