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NCT01190722 Clinical Trial

A Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain

Postoperative Pain Clinical Trial

Official title:
A Randomized Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01190722
Other study ID # 201001HV
Secondary ID
Status Withdrawn
Phase Phase 4
First received August 27, 2010
Last updated November 29, 2017
Start date November 10, 2010
Est. completion date December 12, 2010

Study information
Verified date November 2017
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators hypothesize that cyclooxygenas-II-selective inhibitors (Coxibs) provide a better patients assessed overall satisfaction when used for pain management after elective hallux valgus surgery as compared to traditional Non-steroidal anti-inflammatory drugs (NSAIDs).

Description:

The aim of the present study is to compare patients' satisfaction with pain medication during the first 7 first postoperative days following elective hallux valgus surgery in general anaesthesia between etoricoxib and diclofenac in a prospective randomised double-blind study design.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 12, 2010
Est. primary completion date December 11, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiology (ASA) physiological class 1-2 patients

- aged 18-65 years

- scheduled for elective hallux valgus surgery in general anesthesia

Exclusion Criteria:

- NSAID allergy

- liver disease

- renal disease

- uncontrolled cardiovascular disease

- Lithium therapy

- chronic pain

- regular analgesia use

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• etoricoxib
120 mg once daily for the 1st 6 postoperative days
• Diclofenac
50 mg oral 3 times daily the 1st 6 postoperative days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Karolinska Institutet

Outcome
Type Measure Description Time frame Safety issue
Primary Patients Global Evaluation of Study Medication Patients self-assessment of global satisfaction with pain medication postoperative day 1-6
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