Etoricoxib in Ear Nose Throat Surgery
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|ClinicalTrials.gov Identifier: NCT00756873|
Recruitment Status : Unknown
Verified September 2008 by University of Regensburg.
Recruitment status was: Not yet recruiting
First Posted : September 22, 2008
Last Update Posted : September 22, 2008
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 or disease||Intervention/treatment||Phase|
|Tonsillectomy||Drug: Administration of placebo Drug: Administration of etoricoxib||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Analgesic Efficacy and Safety of Etoricoxib in Ear Nose Throat Surgery|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||September 2009|
|Estimated Study Completion Date :||December 2009|
|Placebo Comparator: 1||
Drug: Administration of placebo
Placebo qd orally day 0-14
Etoricoxib 90 mg qd.
Drug: Administration of etoricoxib
Etoricoxib 90 mg qd orally day 0-14
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
- Post-operative opioid-sparing effect of etoricoxib in humans undergoing elective tonsillectomy [ Time Frame: Day 0-3 after surgery ]
- Impact of etoricoxib medication on PONV or activities of daily or the incidence of postoperative bleeding [ Time Frame: Day 0-14 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756873
|Contact: Michael Bucher, MD, PhD||xx49-941-944- ext firstname.lastname@example.org|
|Universtiy Hospital Regensburg||Not yet recruiting|
|Regensburg, Germany, 93053|
|Contact: Michael Bucher, MD, PhD xx49-941-944- ext 0 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Jürgen Altmeppen, MD|