Analgesic efficacy and safety of etoricoxib in ear nose throat surgery

• Conditions: 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: 9.1Level: LLTClassification code 10044006Term: Tonsillectomy

• Registration Number: EUCTR2007-004274-10-DE
• Lead Sponsor: Freistaat Bayern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-13
• Last Update Posted: 7 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.