Evaluation of acute postsurgery pain management in patients who undergo inguen hernia surgery

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2009
INTERVENTION: 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 Pharmaceutical Form: Coated tablet INN or Proposed INN: TRAMADOLO CLORIDRATO CAS Number: 36282‐47‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 37.5‐ INN or Proposed INN: PARACETAMOLO CAS Number: 103‐90‐2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 37.5‐ CONDITION: Acute post surgery pain in patients who undergo inguen hernia surgery ; MedDRA version: 9.1 Level: LLT Classification code 10019917 PRIMARY OUTCOME: Main Objective: Evaluation of oral administration of ketorolac versus tramadol+paracetamol in acute postsurgery pain management in patients who undergo inguen hernia surgery Primary end point(s): Higher efficacy of treatment B (tramadol+paracetamol) evaluated by Numeric Rate Scale NRS Secondary Objective: Evaluation of presence of possible adverse events Analgesic efficacy in physical recovery Differences in surgical complications Differences in chronic pain 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
Epistemonikos ID: adeac2968c536ba2d1f92c4f5d97782bb9b76493
First added on: Aug 22, 2024