Acute post surgery pain in patients who undergo inguen hernia surgery MedDRA version: 9.1 Level: LLT Classification code 10019917
Conditions
Interventions
Trade Name: TORADOL
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Ketorolac
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: PATROL
Pharma
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age > 18 years; American Society of Anesthesiologists (ASA)I or I; NYHUS type 2, 3a or 3b inguen hernia; planned for monolateral ingeun herna surgery; not opiates absumption; no alteration in the state of mind; signed informed consent 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Intensive care; pregnancy or breast feeding; use of FANS in the previous 5 days; use of MAO-inhibitors in the previous 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of oral administration of ketorolac versus tramadol+paracetamol in acute postsurgery pain management in patients who undergo inguen hernia surgery;Secondary Objective: Evaluation of presence of possible adverse events Analgesic efficacy in physical recovery Differences in surgical complications Differences in chronic pain;Primary end point(s): Higher efficacy of treatment B (tramadol+paracetamol) evaluated by Numeric Rate Scale NRS | — |
Countries
Italy
Outcome results
None listed