Etoricoxib in Ear Nose Throat Surgery

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to test the analgesic efficacy of etoricoxib (90 mg or 120 mg qd. perioperatively) for post-operative pain relief.

The primary endpoint is as follows:

• 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).

The secondary endpoints are as follows:

• does the etoricoxib medication have an impact on PONV or activities of daily

• does the etoricoxib medication influence the blood loss during surgery or the incidence of postoperative bleeding

• does the etoricoxib medication influence the operation time. In addition, adverse effects of etoricoxib will be documented.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Regensburg
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Etoricoxib

Criteria

Inclusion Criteria:

• male or female patients

• 18 years of age

• female patients not pregnant/non-lactating

• indication for elective tonsillectomy

• written informed consent.

Exclusion Criteria:

• etoricoxib, other analgesic or anti-emetic medication within 10 half-lives

• evidence for active peptic ulceration

• 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