TonsillectomyPhase 2NCT00849966
Celecoxib for Pediatric Adenotonsillectomy
A Phase 2 study testing Celebrex suspension in people with Tonsillectomy and Adenotonsillectomy, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
The investigators' study will involve the administration of either placebo or celecoxib to children aged 2 to 18 years of age undergoing tonsillectomy and assessing pain relief, impact on quality of life and side effect profile. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Tonsillectomy, Adenotonsillectomy, Pain, Postoperative
- What is being tested?
- Celebrex suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2009to Dec 2012
- Phase
- Phase 2
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 2-18 years
- Tonsillectomy, or adenotonsillectomy
- No exclusion criteria
Who cannot join
- Age < 2yrs and >18yrs old
- BMI < 10th or > 95th percentile
- Serum creatinine (Cr) > 2 X UNL (upper normal limit)
- Abnormal liver function; namely alanine aminotransferase (ALT) > 1.5 X UNL, alkaline phosphatase (ALP) > 5X UNL, total bilirubin > 2 X UNL
- History of peptic ulcer disease.
- History of bleeding disorders
Show all 13Show fewer
- History of severe asthma (requiring recent hospital admission or oral corticosteroid therapy)
- Allergy to celecoxib, sulfonamide compounds or NSAIDs
- Patients receiving CYP2C9 inhibitors fluconazole, amiodarone and oxandrolone
- Patients receiving CYP2C9 inducers rifampin and phenobarbital
- Extremes of body mass index (BMI) (age related below10th or above 90th percentile)
- Parents of any participants, irrespective of age, who are unable to read and understand instructions relayed in English or French
- Participant and/or parents of any participants, irrespective of age, who suffer from dementia, psychosis, significant developmental delay or other impairment that would prohibit the understanding and giving of informed consent or assent or the participation in self-care or toxicity reporting
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's Hospital of Eastern Ontario
Ottawa, Ontario, ON K1H 8L1
About this study
Official title: Celecoxib for Pediatric Adenotonsillectomy: A Randomized Controlled Double Blinded Study
The investigators' study will involve the administration of either placebo or celecoxib to children aged 2 to 18 years of age undergoing tonsillectomy and assessing pain relief, impact on quality of life and side effect profile.
Read the detailed description
The study will consist of two arms, one placebo and the other celecoxib. To establish baseline data on the day of surgery the parents will be required to complete a validated parent report quality of life inventory, multi-dimension fatigue scale and pediatric pain questionnaire for the preceding week. Children/adolescents aged 8 to 18 years of age will be required to complete a child self-report of the same modules. Children undergoing adenotonsillectomy will receive either placebo or celecoxib by mouth one hour prior to their surgery. They will all receive preoperative acetaminophen. Premedication with midazolam will be at the discretion of the attending anesthesiologist. The patients will undergo a standardized anesthetic protocol including postoperative management of pain and nausea and vomiting. The patients, while under anesthesia, will have blood drawn to screen for occult liver and kidney disease, determine their CYP2C9 genotype and reserve for future gene chip micro array analysis.
Patients in both study arms will receive a second dose of celecoxib or placebo by mouth in the evening after surgery and then consecutively in the morning and evening for 72 hours. For seven days after the surgery the families will record once a day pain scores, document analgesic use and any side effects or adverse events. The families will be contacted by phone in the evening of the first three postoperative days to ensure that they understand and are completing the required documentation. On the seventh postoperative day the parents and children aged 8 to 18 years of age will be contacted by phone and instructed to complete the same two validated questionnaires concerning quality of life and level of fatigue completed on the day of surgery. Parents of children less than eight years of age will be responsible for completing these questionnaires based on observations of their children. On the 11th postoperative day the families will be contacted by e-mail or regular mail to complete a questionnaire asking about the extent of contact with the healthcare system, bleeding complications, recovery and overall satisfaction with their care.
- Conditions
- Tonsillectomy, Adenotonsillectomy, Pain, Postoperative
- Being tested
- Celebrex suspension, Placebo
- Keywords
- Celebrex, celecoxib, Cyclooxygenase Inhibitors, Anti-Inflammatory Agents Non-Steroidal, Adverse drug events, quality of life, Pain Postoperative, Tonsillectomy, Adenotonsillectomy, Otologic Surgical Procedures
- Medical subject headings
- Pain, Postoperative, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celebrex suspensionDrug
Also called celecoxib
Patients will be randomized to receive celecoxib suspension 6 mg/kg one hour prior to their scheduled surgery. In addition the patient will receive seven weight-based doses of celecoxib (3 mg/kg) to be administered every 10-12 hours while the child is awake; the first dose being administered the evening of surgery.
All participants will receive undergo and post surgery anesthetic treatment according to the usual standards of practice at CHEO.
PlaceboDrug
Also called Ora-Blend
Patients will be randomized to receive placebo by mouth one hour prior to their scheduled surgery. In addition the patient will receive seven weight-based doses of the placebo to be administered every 10-12 hours while the child is awake; the first dose being administered the evening of surgery.
All participants will receive undergo and post surgery anesthetic treatment according to the usual standards of practice at CHEO.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Celebrex suspension Receives: Drug: Celebrex suspension |
| B | Placebo comparator | Placebo Receives: Drug: Celebrex suspension; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The investigators primary objective will be to determine the level of postoperative pain relief celecoxib provides for children within the first three days after undergoing tonsillectomy, or adenotonsillectomy
Measured: three days
Secondary outcomes (5)
To measure the frequency of adverse events post surgery
Measured: For seven days immediately after the procedure
To quantify the impact of celecoxib on fatigue
Measured: Day 0 before the procedure and again on Day 7 afterwards
To quantify the impact of celecoxib on quality of life
Measured: Day 0 before the procedure and again on Day 7 afterwards
To quantify the impact of celecoxib on pain relief postsurgery
Measured: Day 0 before the procedure and every day until Day 7 afterwards
To identify polymorphisms of CYP2C9 genotypes and their impact on pain relief.
Measured: Sample taken during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Responsible party
- Principal investigator, Kimmo Murto, Children's Hospital of Eastern Ontario
- Investigators
- Kimmo Murto, MD, FRCPC, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849966
- Sponsor's protocol ID
- #09/10E
- Status last verified
- Apr 2013
- First submitted
- 20 Feb 2009
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Murto K, Lamontagne C, McFaul C, MacCormick J, Ramakko KA, Aglipay M, Rosen D, Vaillancourt R. Celecoxib pharmacogenetics and pediatric adenotonsillectomy: a double-blinded randomized controlled study. Can J Anaesth. 2015 Jul;62(7):785-97. doi: 10.1007/s12630-015-0376-1. Epub 2015 Apr 7.
PubMed 25846344
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celecoxib for Pediatric Adenotonsillectomy: A Randomized Controlled Double Blinded Study
- ClinicalTrials.gov ID
- NCT00849966
- Acronym / sponsor ID
- #09/10E
- Conditions
- Tonsillectomy, Adenotonsillectomy, Pain, Postoperative
- Keywords
- Celebrex, celecoxib, Cyclooxygenase Inhibitors, Anti-Inflammatory Agents Non-Steroidal, Adverse drug events, quality of life, Pain Postoperative, Tonsillectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- University of Ottawa
- Study start
- Aug 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Feb 2009 (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 investigators' study will involve the administration of either placebo or celecoxib to children aged 2 to 18 years of age undergoing tonsillectomy and assessing pain relief, impact on quality of life and side effect profile.
Detailed description
The study will consist of two arms, one placebo and the other celecoxib. To establish baseline data on the day of surgery the parents will be required to complete a validated parent report quality of life inventory, multi-dimension fatigue scale and pediatric pain questionnaire for the preceding week. Children/adolescents aged 8 to 18 years of age will be required to complete a child self-report of the same modules. Children undergoing adenotonsillectomy will receive either placebo or celecoxib by mouth one hour prior to their surgery. They will all receive preoperative acetaminophen. Premedication with midazolam will be at the discretion of the attending anesthesiologist. The patients will undergo a standardized anesthetic protocol including postoperative management of pain and nausea and vomiting. The patients, while under anesthesia, will have blood drawn to screen for occult liver and kidney disease, determine their CYP2C9 genotype and reserve for future gene chip micro array analysis.
Patients in both study arms will receive a second dose of celecoxib or placebo by mouth in the evening after surgery and then consecutively in the morning and evening for 72 hours. For seven days after the surgery the families will record once a day pain scores, document analgesic use and any side effects or adverse events. The families will be contacted by phone in the evening of the first three postoperative days to ensure that they understand and are completing the required documentation. On the seventh postoperative day the parents and children aged 8 to 18 years of age will be contacted by phone and instructed to complete the same two validated questionnaires concerning quality of life and level of fatigue completed on the day of surgery. Parents of children less than eight years of age will be responsible for completing these questionnaires based on observations of their children. On the 11th postoperative day the families will be contacted by e-mail or regular mail to complete a questionnaire asking about the extent of contact with the healthcare system, bleeding complications, recovery and overall satisfaction with their care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Celebrex suspensionCelebrex suspension |
| B | Placebo comparator | Drug: Celebrex suspension, Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children aged 2-18 years
- Tonsillectomy, or adenotonsillectomy
- No exclusion criteria
Key exclusion criteria (13 listed)
- Age < 2yrs and >18yrs old
- BMI < 10th or > 95th percentile
- Serum creatinine (Cr) > 2 X UNL (upper normal limit)
- Abnormal liver function; namely alanine aminotransferase (ALT) > 1.5 X UNL, alkaline phosphatase (ALP) > 5X UNL, total bilirubin > 2 X UNL
- History of peptic ulcer disease.
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 |
|---|---|---|
| Celebrex suspensionAlso: celecoxibPatients will be randomized to receive celecoxib suspension 6 mg/kg one hour prior to their scheduled surgery. In addition the patient will receive seven weight-based doses of celecoxib (3 mg/kg) to be administered every 10-12 hours while the child is awake; the first dose being administered the evening of surgery. All participants will receive undergo and post surgery anesthetic treatment according to the usual standards of practice at CHEO. | Drug | A, B |
| PlaceboAlso: Ora-BlendPatients will be randomized to receive placebo by mouth one hour prior to their scheduled surgery. In addition the patient will receive seven weight-based doses of the placebo to be administered every 10-12 hours while the child is awake; the first dose being administered the evening of surgery. All participants will receive undergo and post surgery anesthetic treatment according to the usual standards of practice at CHEO. | Drug | B |
Primary outcome
The investigators primary objective will be to determine the level of postoperative pain relief celecoxib provides for children within the first three days after undergoing tonsillectomy, or adenotonsillectomy
Time frame: three days
5 secondary outcomes
To measure the frequency of adverse events post surgery
Time frame: For seven days immediately after the procedure
To quantify the impact of celecoxib on fatigue
Time frame: Day 0 before the procedure and again on Day 7 afterwards
To quantify the impact of celecoxib on quality of life
Time frame: Day 0 before the procedure and again on Day 7 afterwards
To quantify the impact of celecoxib on pain relief postsurgery
Time frame: Day 0 before the procedure and every day until Day 7 afterwards
To identify polymorphisms of CYP2C9 genotypes and their impact on pain relief.
Time frame: Sample taken during the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2013.
- Derived from this study: PubMed 25846344Murto K, Lamontagne C, McFaul C, MacCormick J, Ramakko KA, Aglipay M, Rosen D, Vaillancourt R. Celecoxib pharmacogenetics and pediatric adenotonsillectomy: a double-blinded randomized controlled study. Can J Anaesth. 2015 Jul;62(7):785-97. doi: 10.1007/s12630-015-0376-1. Epub 2015 Apr 7.
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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.
Kimmo Murto, MD, FRCPC principal investigator
Children's Hospital of Eastern Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celebrex suspension in people with Tonsillectomy and Adenotonsillectomy, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 18 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The investigators primary objective will be to determine the level of postoperative pain relief celecoxib provides for children within the first three days after undergoing tonsillectomy, or adenotonsillectomy (time frame: three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00849966, which also lists 1 linked publication.
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 18 Apr 2013.