Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty
etoketo
The Central Nervous Penetration of Dexketoprofen and Etoricoxib and Their Effect on Pain and Inflammatory Reaction in Patients Undergoing Hip Arthroplasty
1 other identifier
interventional
24
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 6, 2015
CompletedMay 3, 2016
April 1, 2016
1.9 years
October 5, 2015
April 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cerebrospinal fluid concentration dexketoprofen and etoricoxib
Cerebrospinal fluid concentration of dexketoprofen and etoricoxib
0-24 hours
Plasma concentration dexketoprofen and etoricoxib
Plasma concentration dexketoprofen and etoricoxib
0-24 hours
Secondary Outcomes (1)
Pain
0-24 h
Study Arms (2)
Etoricoxib
EXPERIMENTALEtoricoxib 60mg if body weight≤ 60kg, 90mg if body weight 61-90kg and 120mg if body weight\> 90kg by mouth
Dexketoprofen
ACTIVE COMPARATORDexketoprofen 0,5 mg/kg up to 50 mg intravenously
Interventions
After total hip replacement surgery patient were given either etoricoxib or dexketoprofen
After total hip replacement surgery patient were given either etoricoxib or dexketoprofen
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 5, 2015
First Posted
October 6, 2015
Study Start
January 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
May 3, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share