Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty (etoketo)
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexketoprofen
Etoricoxib
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Dexketoprofen, Etoricoxib, hip arthroplasty, pain
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Etoricoxib
Dexketoprofen
Arm Description
Etoricoxib 60mg if body weight≤ 60kg, 90mg if body weight 61-90kg and 120mg if body weight> 90kg by mouth
Dexketoprofen 0,5 mg/kg up to 50 mg intravenously
Outcomes
Primary Outcome Measures
Cerebrospinal fluid concentration dexketoprofen and etoricoxib
Cerebrospinal fluid concentration of dexketoprofen and etoricoxib
Plasma concentration dexketoprofen and etoricoxib
Plasma concentration dexketoprofen and etoricoxib
Secondary Outcome Measures
Pain
Pain assessed with numeral rating scale
Full Information
NCT ID
NCT02568735
First Posted
October 5, 2015
Last Updated
April 30, 2016
Sponsor
Kuopio University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02568735
Brief Title
Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty
Acronym
etoketo
Official Title
The Central Nervous Penetration of Dexketoprofen and Etoricoxib and Their Effect on Pain and Inflammatory Reaction in Patients Undergoing Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Dexketoprofen, Etoricoxib, hip arthroplasty, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etoricoxib
Arm Type
Experimental
Arm Description
Etoricoxib 60mg if body weight≤ 60kg, 90mg if body weight 61-90kg and 120mg if body weight> 90kg by mouth
Arm Title
Dexketoprofen
Arm Type
Active Comparator
Arm Description
Dexketoprofen 0,5 mg/kg up to 50 mg intravenously
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen
Intervention Description
After total hip replacement surgery patient were given either etoricoxib or dexketoprofen
Intervention Type
Drug
Intervention Name(s)
Etoricoxib
Intervention Description
After total hip replacement surgery patient were given either etoricoxib or dexketoprofen
Primary Outcome Measure Information:
Title
Cerebrospinal fluid concentration dexketoprofen and etoricoxib
Description
Cerebrospinal fluid concentration of dexketoprofen and etoricoxib
Time Frame
0-24 hours
Title
Plasma concentration dexketoprofen and etoricoxib
Description
Plasma concentration dexketoprofen and etoricoxib
Time Frame
0-24 hours
Secondary Outcome Measure Information:
Title
Pain
Description
Pain assessed with numeral rating scale
Time Frame
0-24 h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty
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