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Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty (etoketo)

K

Kuopio University Hospital

Status and phase

Completed
Phase 4

Conditions

Pain, Postoperative

Treatments

Drug: Etoricoxib
Drug: Dexketoprofen

Study type

Interventional

Funder types

Other

Identifiers

NCT02568735
KUH30062008

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Etoricoxib
Experimental group
Description:
Etoricoxib 60mg if body weight≤ 60kg, 90mg if body weight 61-90kg and 120mg if body weight\> 90kg by mouth
Treatment:
Drug: Etoricoxib
Dexketoprofen
Active Comparator group
Description:
Dexketoprofen 0,5 mg/kg up to 50 mg intravenously
Treatment:
Drug: Dexketoprofen

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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