Etoricoxib in Ear Nose Throat Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University of Regensburg.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Regensburg
ClinicalTrials.gov Identifier:
NCT00756873
First received: September 19, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.

Condition Intervention Phase
Tonsillectomy
Drug: Administration of placebo
Drug: Administration of etoricoxib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Analgesic Efficacy and Safety of Etoricoxib in Ear Nose Throat Surgery

Resource links provided by NLM:


Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • Post-operative opioid-sparing effect of etoricoxib in humans undergoing elective tonsillectomy [ Time Frame: Day 0-3 after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Impact of etoricoxib medication on PONV or activities of daily or the incidence of postoperative bleeding [ Time Frame: Day 0-14 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: October 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Administration of placebo
Placebo qd orally day 0-14
Experimental: 2
Etoricoxib 90 mg qd.
Drug: Administration of etoricoxib
Etoricoxib 90 mg qd orally day 0-14
Experimental: 3
Etoricoxib 120 mg qd. (day 0-7) Etoricoxib 90 mg qd. (day 8-14)
Drug: Administration of etoricoxib
Etoricoxib 120 mg qd orally day 0-7 Etoricoxib 90 mg qd orally day 8-14

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756873

Contacts
Contact: Michael Bucher, MD, PhD xx49-941-944- ext 0 michael.bucher@klinik.uni-regensburg.de

Locations
Germany
Universtiy Hospital Regensburg Not yet recruiting
Regensburg, Germany, 93053
Contact: Michael Bucher, MD, PhD    xx49-941-944- ext 0    michael.bucher@klinik.uni.regensburg.de   
Principal Investigator: Michael Bucher, MD, PhD         
Sub-Investigator: Thomas Kühnel, MD, PhD         
Weiden Clinic Not yet recruiting
Weiden i.d. OPf., Germany, 92637
Contact: Jürgen Altmeppen, MD    xx49-9 61-303- ext 32 02    anaesthesie@klinikum-weiden.de   
Principal Investigator: Jürgen Altmeppen, MD         
Sponsors and Collaborators
University of Regensburg
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Michael Bucher, MD, PhD, University Hospital Regensburg
ClinicalTrials.gov Identifier: NCT00756873     History of Changes
Other Study ID Numbers: Etoric-TE-1
Study First Received: September 19, 2008
Last Updated: September 19, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Regensburg:
Elective tonsillectomy

Additional relevant MeSH terms:
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014