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Sponsors and Collaborators: |
University of Regensburg MSD Sharp & Dohme GmbH |
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Information provided by: | University of Regensburg |
ClinicalTrials.gov Identifier: | NCT00756873 |
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:
The secondary endpoints are as follows:
Condition | Intervention | Phase |
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Tonsillectomy |
Drug: Administration of placebo Drug: Administration of etoricoxib |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Analgesic Efficacy and Safety of Etoricoxib in Ear Nose Throat Surgery |
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 |
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1: Placebo Comparator |
Drug: Administration of placebo
Placebo qd orally day 0-14
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2: Experimental
Etoricoxib 90 mg qd.
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Drug: Administration of etoricoxib
Etoricoxib 90 mg qd orally day 0-14
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3: Experimental
Etoricoxib 120 mg qd. (day 0-7) Etoricoxib 90 mg qd. (day 8-14)
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Drug: Administration of etoricoxib
Etoricoxib 120 mg qd orally day 0-7 Etoricoxib 90 mg qd orally day 8-14
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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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Bucher, MD, PhD | xx49-941-944- ext 0 | michael.bucher@klinik.uni-regensburg.de |
Germany | |
Universtiy Hospital Regensburg | |
Regensburg, Germany, 93053 | |
Weiden Clinic | |
Weiden i.d. OPf., Germany, 92637 |
Responsible Party: | University Hospital Regensburg ( Michael Bucher, MD, PhD ) |
Study ID Numbers: | Etoric-TE-1 |
Study First Received: | September 19, 2008 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00756873 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Elective tonsillectomy |
Anti-Inflammatory Agents Analgesics, Non-Narcotic Cyclooxygenase Inhibitors Etoricoxib |
Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Etoricoxib Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |