Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty

NCT ID: NCT02568735

Last Updated: 2016-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etoricoxib

Etoricoxib 60mg if body weight≤ 60kg, 90mg if body weight 61-90kg and 120mg if body weight\> 90kg by mouth

Group Type EXPERIMENTAL

Etoricoxib

Intervention Type DRUG

After total hip replacement surgery patient were given either etoricoxib or dexketoprofen

Dexketoprofen

Dexketoprofen 0,5 mg/kg up to 50 mg intravenously

Group Type ACTIVE_COMPARATOR

Dexketoprofen

Intervention Type DRUG

After total hip replacement surgery patient were given either etoricoxib or dexketoprofen

Interventions

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Dexketoprofen

After total hip replacement surgery patient were given either etoricoxib or dexketoprofen

Intervention Type DRUG

Etoricoxib

After total hip replacement surgery patient were given either etoricoxib or dexketoprofen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Merja Kokki

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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KUH30062008

Identifier Type: -

Identifier Source: org_study_id

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