TonsillectomyPhase 3NCT00756873
Etoricoxib in Ear Nose Throat Surgery
A Phase 3 study testing Administration of etoricoxib in people with Tonsillectomy, run by University of Regensburg at 2 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- Administration of etoricoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2008to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female patients
- 18 years of age
- female patients not pregnant/non-lactating
- indication for elective tonsillectomy
- written informed consent.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Universtiy Hospital Regensburg
Regensburg, 93053
Michael Bucher, MD, PhD, xx49-941-944- ext. 0, michael.bucher@klinik.uni.regensburg.de
Michael Bucher, MD, PhD
Weiden Clinic
Weiden I.d. OPf., 92637
Jürgen Altmeppen, MD, xx49-9 61-303- ext. 32 02, anaesthesie@klinikum-weiden.de
Jürgen Altmeppen, MD
About this study
Official title: Analgesic Efficacy and Safety of Etoricoxib in Ear Nose Throat Surgery
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:
Read more
- 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.
Read the 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
- Being tested
- Administration of placebo, Administration of etoricoxib
- Keywords
- Elective tonsillectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of placeboDrug
Placebo qd orally day 0-14
Administration of etoricoxibDrug
Etoricoxib 90 mg qd orally day 0-14
Administration of etoricoxibDrug
Etoricoxib 120 mg qd orally day 0-7 Etoricoxib 90 mg qd orally day 8-14
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Administration of placebo |
| 2 | Experimental | Etoricoxib 90 mg qd. Receives: Drug: Administration of etoricoxib |
| 3 | Experimental | Etoricoxib 120 mg qd. (day 0-7) Etoricoxib 90 mg qd. (day 8-14) Receives: Drug: Administration of etoricoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative opioid-sparing effect of etoricoxib in humans undergoing elective tonsillectomy
Measured: Day 0-3 after surgery
Secondary outcomes (1)
Impact of etoricoxib medication on PONV or activities of daily or the incidence of postoperative bleeding
Measured: Day 0-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionSep 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756873
- Sponsor's protocol ID
- Etoric-TE-1
- Status last verified
- Sep 2008
- First submitted
- 19 Sep 2008
- Last updated
- 22 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy and Safety of Etoricoxib in Ear Nose Throat Surgery
- ClinicalTrials.gov ID
- NCT00756873
- Acronym / sponsor ID
- Etoric-TE-1
- Conditions
- Tonsillectomy
- Keywords
- Elective tonsillectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Oct 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Administration of placebo |
| 2 | Experimental | Drug: Administration of etoricoxibEtoricoxib 90 mg qd. |
| 3 | Experimental | Drug: Administration of etoricoxibEtoricoxib 120 mg qd. (day 0-7) Etoricoxib 90 mg qd. (day 8-14) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male or female patients
- 18 years of age
- female patients not pregnant/non-lactating
- indication for elective tonsillectomy
- written informed consent.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of placeboPlacebo qd orally day 0-14 | Drug | 1 |
| Administration of etoricoxibEtoricoxib 90 mg qd orally day 0-14 | Drug | 2 |
| Administration of etoricoxibEtoricoxib 120 mg qd orally day 0-7 Etoricoxib 90 mg qd orally day 8-14 | Drug | 3 |
Primary outcome
Post-operative opioid-sparing effect of etoricoxib in humans undergoing elective tonsillectomy
Time frame: Day 0-3 after surgery
1 secondary outcome
Impact of etoricoxib medication on PONV or activities of daily or the incidence of postoperative bleeding
Time frame: Day 0-14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Administration of etoricoxib in people with Tonsillectomy, run by University of Regensburg at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Bucher, MD, PhD (xx49-941-944- ext. 0, michael.bucher@klinik.uni-regensburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative opioid-sparing effect of etoricoxib in humans undergoing elective tonsillectomy (time frame: Day 0-3 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2008.