A Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain
Overview
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).
Full Title of Study: “A Randomized Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: December 11, 2010
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.
Interventions
- Drug: etoricoxib
- 120 mg once daily for the 1st 6 postoperative days
- Drug: Diclofenac
- 50 mg oral 3 times daily the 1st 6 postoperative days
Arms, Groups and Cohorts
- Experimental: etoricoxib
- active study drug, coxib
- Active Comparator: diclofenac
- active traditional NSAID control
Clinical Trial Outcome Measures
Primary Measures
- Patients Global Evaluation of Study Medication
- Time Frame: postoperative day 1-6
- Patients self-assessment of global satisfaction with pain medication
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Karolinska Institutet
- Provider of Information About this Clinical Study
- Principal Investigator: Jan Jakobsson, Adj. Professor – Karolinska Institutet
- Overall Official(s)
- Jan Jakobsson, Professor, Principal Investigator, Karolinska Institutet
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