A Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain
Information source: Karolinska Institutet
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hallux Valgus; Postoperative Pain
Intervention: etoricoxib (Drug); Diclofenac (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Karolinska Institutet Official(s) and/or principal investigator(s):
Jan Jakobsson, Professor, Principal Investigator, Affiliation: Karolinska Institutet
Overall contact:
Jan Jakobsson, Professor, Phone: 46702500960, Email: jan.jakobsson@ki.se
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).
Clinical Details
Official title: A Randomized Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Patients Global Evaluation of Study Medication
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jan Jakobsson, Professor, Phone: 46702500960, Email: jan.jakobsson@ki.se
Foot & ANkle Surgical Centre, Stockholm, Östermalm 11542, Sweden
Additional Information
Starting date: November 2010
Last updated: August 27, 2010
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