Postoperative pain, pain following elective Hallux Valgus surery ad modum Turan MedDRA version: 9.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief
Conditions
Interventions
Trade Name: Arcoxia
Product Name: Arcoxia
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Enteral use (Noncurrent)
Trade Name: Tiparol
P
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy (ASA 1-2) patient schedueled for elective Hallux Valgus surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy NSAID/Coxib allergy Complicated medical condition (ASA > 2) Uncontrolled heart, vascular, liver, renal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study if a coxib as part of the standard pain management can clinically relevant decrease postoperative pain and discomfort after elective Hallux Valgus surgery;Secondary Objective: To study if a coxib as part of the standard pain management can clinically relevant decrease common side effects seen emesis, obstipation and dizziness;Primary end point(s): Need for rescue medication | — |
Countries
Sweden
Outcome results
None listed