etoketo: Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty

Sponsor

Kuopio University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02568735

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Dexketoprofen Drug: Etoricoxib	Phase 4

Study Design

Study Type:

Interventional

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 :

Jan 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Cerebrospinal fluid concentration dexketoprofen and etoricoxib [0-24 hours]
Cerebrospinal fluid concentration of dexketoprofen and etoricoxib
Plasma concentration dexketoprofen and etoricoxib [0-24 hours]
Plasma concentration dexketoprofen and etoricoxib

Secondary Outcome Measures

Pain [0-24 h]
Pain assessed with numeral rating scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kuopio University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Merja Kokki, MD, PhD, Kuopio University Hospital

ClinicalTrials.gov Identifier:

NCT02568735

Other Study ID Numbers:

KUH30062008

First Posted:

Oct 6, 2015

Last Update Posted:

May 3, 2016

Last Verified:

Apr 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Merja Kokki, MD, PhD, Kuopio University Hospital

Additional relevant MeSH terms:

Pain, Postoperative

Etoricoxib

Dexketoprofen trometamol

Study Results

No Results Posted as of May 3, 2016