Etoricoxib in Ear Nose Throat Surgery

NCT ID: NCT00756873

Last Updated: 2008-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-12-31

Brief 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.

Detailed Description

On day of surgery (day 0) the patients will be randomly assigned to one of the three groups using a sealed envelope method. The etoricoxib 90 mg group receives etoricoxib (Arcoxia®, Merck Sharp & Dohme GmbH, Haar, Germany) 90 mg orally, the etoricoxib 120 mg group receives etoricoxib 120 mg orally and the control group receives a placebo tablet orally 1 h before surgery (day 0). All patients receive a standard general anesthesia with intravenous propofol (2-3 mg/kg), fentanyl (2 µg/kg) and mivacurium (0.2 mg/kg) for induction. Patients are ventilated via a tracheal tube, anesthesia being maintained with sevoflurane (0.8 - 1.5% end-tidal concentration). If mean arterial blood pressure or heart rate increase to more than 25% above the pre-operative baseline value despite an end-tidal concentration of 1.5% sevoflurane, an intravenous bolus of fentanyl 0.05 mg will be administered. Monitoring includes electrocardiogram (ECG), non-invasive arterial blood pressure, pulse oximetry, end-tidal CO2 and end-tidal sevoflurane. On days 1 to 3 patients will receive etoricoxib (90 mg or 120 mg qd.) or placebo. After discharge on day 3, patients will receive etoricoxib (90 mg or 120 mg qd.) or placebo until cessation of pain during activity (swallowing). According to the current label for Arcoxia® 120 mg in Germany, patients taking etoricoxib 120 mg will switch to etoricoxib 90 mg on day 8. Rescue medication will be piritramid i.v. (day 0), oxycodone p.o. (day 1-2) and paracetamol p.o. (day 3-14).

Day -7 to -1: Inclusion/exclusion criteria, medical history, concomitant medications, laboratory, serum pregnancy test, informed consent Day 0: Study medication 1 h before surgery, intra-operative blood loss, pain score, opioid utilization, PONV score and anti-emetic medication Day 1: pain score, opioid utilization, PONV score, anti-emetic medication, bleeding Day 2: pain score, opioid utilization, PONV score, anti-emetic medication, bleeding Day 3: pain score, opioid utilization, PONV score, anti-emetic medication, bleeding Day 7: pain score, paracetamol utilization, bleeding Day 14: first day with no pain, last study medication, paracetamol utilization, bleeding

Conditions

Tonsillectomy

Keywords

Elective tonsillectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: PLACEBO_COMPARATOR

Administration of placebo

Intervention Type: DRUG

Placebo qd orally day 0-14

2

Etoricoxib 90 mg qd.

Group Type: EXPERIMENTAL

Administration of etoricoxib

Intervention Type: DRUG

Etoricoxib 90 mg qd orally day 0-14

3

Etoricoxib 120 mg qd. (day 0-7) Etoricoxib 90 mg qd. (day 8-14)

Group Type: EXPERIMENTAL

Administration of etoricoxib

Intervention Type: DRUG

Etoricoxib 120 mg qd orally day 0-7 Etoricoxib 90 mg qd orally day 8-14

Interventions

Administration of placebo

Placebo qd orally day 0-14

Intervention Type: DRUG

Administration of etoricoxib

Etoricoxib 90 mg qd orally day 0-14

Intervention Type: DRUG

Administration of etoricoxib

Etoricoxib 120 mg qd orally day 0-7 Etoricoxib 90 mg qd orally day 8-14

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Regensburg

OTHER

Sponsor Role: lead

Responsible Party

University Hospital Regensburg

Locations

Universtiy Hospital Regensburg

Regensburg, , Germany

Weiden Clinic

Weiden I.d. OPf., , Germany

Countries

Germany

Central Contacts

Michael Bucher, MD, PhD

Role: CONTACT

Phone: xx49-941-944-

Email: michael.bucher@klinik.uni-regensburg.de

Facility Contacts

Michael Bucher, MD, PhD

Role: primary

Jürgen Altmeppen, MD

Role: primary

Other Identifiers

Etoric-TE-1

Identifier Type: -

Identifier Source: org_study_id