The aim of this study is to test the analgesic efficacy and safety of etoricoxib (90 mg or 120 mg qd. perioperatively) for post-operative pain relief in tonsillectomy patients. MedDRA version: 9.1 Level: LLT Classification code 10044006 Term: Tonsillectomy
Conditions
Interventions
Trade Name: Arcoxia 90 mg Filmtablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Etoricoxib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Pha
Sponsors
Freistaat Bayern
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: male or female patients older than 18 years of age female patients not pregnant/non-lactating indication for elective tonsillectomy written 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: Etoricoxib, other analgesic or anti-emetic medication within 10 half-lives evidence for active peptic ulceration or history of gastrointestinal bleeding evidence of hepatic, renal or hematopoietic disorders heart failure (NYHA II-IV) uncontrolled arterial hypertension clinical evidence of arterial occlusive disease, coronary heart disease or cerebrovascular disease inflammatory bowel disease hypersensitivity to analgetics, antipyretics, NSAIDs or antiemetics evidence for noncompliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): post-operative opioid utilization in patients undergoing elective tonsillectomy;Main Objective: The aim of this study is to test the analgesic efficacy and safety of etoricoxib (90 mg or 120 mg qd. perioperatively) for post-operative pain relief. The primary endpoint is as follows: (i) does preoperative etoricoxib reduce the post-operative opioid utilization in patients undergoing elective tonsillectomy under general anaesthesia (i.e. the post-operative opioid-sparing effect of etoricoxib in humans). ;Secondary Objective: The secondary endpoints are as follows: (ii) does the etoricoxib medication have an impact on PONV or activities of daily; (iii) does the etoricoxib medication influence the blood loss during surgery or the incidence of postoperative bleeding; and (iv) does the etoricoxib medication influence the operation time. In addition, adverse effects of etoricoxib will be documented. | — |
Countries
Germany
Outcome results
None listed