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Trial registered on ANZCTR


Registration number
ACTRN12611000352909
Ethics application status
Not yet submitted
Date submitted
26/02/2011
Date registered
5/04/2011
Date last updated
5/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Parecoxib in Children
Scientific title
The Pharmacokinetic and Pharmacodynamic of Parecoxib in Children
Secondary ID [1] 259683 0
Nil
Secondary ID [2] 259903 0
nil
Universal Trial Number (UTN)
U1111-1119-0062
Trial acronym
Not applicable
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The Pharmacokinetic and Pharmacodynamics of Parecoxib.

The perioperative pain relief in children and the effects of parecoxib in children 261252 0
Condition category
Condition code
Anaesthesiology 259405 259405 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Research Design
Parecoxib is a intravenous drug and will be administered as a single bolus injection at the induction of anaesthesia for the purpose of this study.
Recruitment
Group 1
-60 patients age 4 to 15yr.
-This allows for the loss of patients either to refusal for further investigations or cannula malfunction.
-Tonsillectomy model is being utilised for this study
-Patients undergoing tonsillectomy with or without adenoidectomy will be recruited
Parental or patient consent will be obtained
Patients in group 1 will be randomised to receive parecoxib in either one of these doses 0.25mg/kg, 1mg/kg or 2mg/kg.
-Patients will then have 6 blood assays taken in total
- 1st blood assay 30 minutes post administration of drug
-2nd blood assay in post anaesthesia care unit
- 3rd to 6th blood assay taken in day stay unit at 30 minute to 1 hour intervals
-Pain scores will also be taken simultaneously with blood assay 2-6

Group 2
-All patients in group 2 will receive 1mg/kg of parecoxib as a single bolus at induction of anaesthesia.
-15 patients age 4 to 15yr.
-General or Orthopaedic patients


All study patients will receive the following drugs.
Paracetamol 30mg/kg orally as per day stay protocol prior to induction.
Intravenous induction using propofol 2-3mg kg -1 or inhalation induction using sevoflurane.
Anaesthesia will be maintained using total intravenous anaesthesia (TIVA), propofol and remifentanil infusion will be used. Lignocaine 1-2mg kg -1 will be used to spray the vocal cords prior to intubation.
Ondansetron 0.15mg kg -1 and Dexamethasone 0.15mg kg -1will be used as antiemetics for Group 1 patients. Ondansetron 0.15mg kg -1 will only be given at the discretion of the anaesthetist for the Group 2 patients.
Intervention code [1] 258113 0
Treatment: Drugs
Comparator / control treatment
Patients will be randomised into 3 groups with the following doses 0.5mg/kg, 1mg/kg and 3mg/kg. There will be no control group as this trial is looking comparing the effect of different doses of Parecoxib to ascertain the appropriate pain relief dose of Parecoxib in children.
Control group
Dose comparison

Outcomes
Primary outcome [1] 262214 0
1) Pain scores of patients in Group1 receiving either 0.25mg/kg, 1mg/kg and 2mg/kg of Parecoxib. Patients will have pain scores done in the post anaesthesia care unit and with simultaneously with blood assay 3-6 on the ward. Revised faces pain scale will be utilised. Pain score will be used as an effect of the pharmacodynamic of Parecoxib
Timepoint [1] 262214 0
Pain scores will be done for group 1 patients only.
1st pain score - in post anaesthesia care unit approximately 40 minutes post administration of drug
2nd to 5th pain score - done simultaneously with blood assay 3rd -6th of parecoxib on the day stay unit. This will be at 30 min to 1 hour intervals. Therefore, this will be at 30 min to 1 hour intervals for 4hours after administration of the parecoxib.
Pain scores will not be done for patients in Group2
Primary outcome [2] 262215 0
Blood tests will be taken when the pain scores are done to test for Parecoxib levels
Timepoint [2] 262215 0
For patients in Group 1:
Sample 1 will be taken after parecoxib has been administered in theatre.
Sample 2 will be taken in the post anaesthesia care unit.
Samples 3 at 1-2 hr post dose, sample 4 at 2-3hr, sample 5 at 3-4hr, sample 6 at 4-5hr.

For patients in Group 2:
Blood levels for Parecoxib will be taken at 12hours post dose
Secondary outcome [1] 273345 0
Nil
Timepoint [1] 273345 0
Nil

Eligibility
Key inclusion criteria
Group 1- Patients undergoing tonsillectomy with or without adnenoidectomy

Group2 - Patients undergoing appendicectomy or repair of fractures
Minimum age
4 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
EXCLUSION CRITERIA IN BOTH GROUPS
Patients with hepatic, renal or cardiac sequelae.
Learning difficulties.
Coagulation defects.
Allergy to NSAIDS.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group 1
-Parents will be sent patient information leaflets with the booking letters prior to the surgery. Therefore, they will have the time to consider the enrolment at their leisure.
- Patients will be recruited by the research nurse or the anaesthetist running the list. Once the parents or patients have shown an interest the research nurse will then discuss the trial with the parent.
- Patients in Group1 will then be randomised to either receive 0.25mg/kg, 1mg/kg or 2mg/kg of Parecoxib during the induction of anaesthesia. They will only receive one dose or parecoxib.
- Once randomisation has occurred the anaesthetic team, post anaesthesia care unit team, research nurse and day stay unit nurses will be blinded to the dose the patient will receive.

BLINDING
-The drug will be reconstituted in a separate room by a separate anaesthetist who will not be involved in the care and subsequent pain analysis of the patient.
-Irrespective the dose the drug will be reconstituted to a volume of 2ml thus blinding the primary anaesthetist to the dose of the drug.
-The dose that the patient has been randomised to will be logged on the research computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
RANDOMISATION
-20 cards with the respective doses mentioned above (total 60 cards) will be placed in a box.
-When the patient has been selected a second anaesthetist will then pick a card from the mentioned box and the dose will then be allocated to the patient.
-As mentioned above only the second anaesthetist will have knowledge of the drug allocation and will reconstitute the appropriate dose of parecoxib.
-The allocation will then be logged on the research computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 3238 0
New Zealand
State/province [1] 3238 0
Auckland

Funding & Sponsors
Funding source category [1] 258569 0
Commercial sector/Industry
Name [1] 258569 0
Pfizer
Country [1] 258569 0
New Zealand
Primary sponsor type
Individual
Name
Dr. Elsa Taylor
Address
Anaesthesia and Operating Rooms,
Starship Children's Health
2 Park Rd Grafton
1023 Auckland
Country
New Zealand
Secondary sponsor category [1] 257709 0
Individual
Name [1] 257709 0
Dr. Lena Tan
Address [1] 257709 0
Anaesthesia and Operating Rooms,
Starship Children's Health
2 Park Rd Grafton
1023 Auckland
Country [1] 257709 0
New Zealand
Secondary sponsor category [2] 257710 0
Individual
Name [2] 257710 0
Prof Brian Anderson
Address [2] 257710 0
Anaesthesia and Operating Rooms,
Starship Children's Health
2 Park Rd Grafton
1023 Auckland
Country [2] 257710 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260554 0
Northern X Ethics Committee
Ethics committee address [1] 260554 0
Postal address:
650 Great South Rd Penrose 1061
Ethics committee country [1] 260554 0
New Zealand
Date submitted for ethics approval [1] 260554 0
01/03/2011
Approval date [1] 260554 0
Ethics approval number [1] 260554 0

Summary
Brief summary
Intravenous non-steroidal anti-inflammatory (NSAIDs) parecoxib has been utilised in both adult and paediatric practice for some years. However, there is only adult data on the pharmacokinetic and pharmacodynamics of parecoxib. There is currently no data regarding the appropriate dose in paediatrics. NSAIDS in paediatric practice are usually administered via the oral or rectal route. However, the bioavailability of these routes are variable and inconsistent. NSAIDS when used with paracetamol are effective as morphine sparing analgesia especially in day surgery. Numerous studies have been done on the pharmacokinetics of other nonsteroidals like ketorolac and diclofenac. Group 1 patients will provide data on the pharmacokinetics and pharmacodynamics of Parecoxib. Group1 patients are day stay patients thus will be discharged within 6 hours. As Parecoxib has a half life of 6-8 hours we require data from Group 2. Group 2 patients will be inpatients who will provide pharmacokinetic data beyond 6 hours. We would like to study the effects of Parecoxib in children in order to find the appropriate pain relieving dose
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 32273 0
Address 32273 0
Country 32273 0
Phone 32273 0
Fax 32273 0
Email 32273 0
Contact person for public queries
Name 15520 0
Lena Tan
Address 15520 0
Anaesthesia & Operating Rooms
Starship Children's Health,
2 Park Road
Grafton 1023
Auckland
Country 15520 0
New Zealand
Phone 15520 0
+64226700449
Fax 15520 0
Email 15520 0
[email protected]
Contact person for scientific queries
Name 6448 0
Dr. Lena Tan
Address 6448 0
Anaesthesia & Operating Rooms
Starship Children's Health,
2 Park Road
Grafton 1023
Auckland
Country 6448 0
New Zealand
Phone 6448 0
+64226700449
Fax 6448 0
Email 6448 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePharmacokinetics and analgesic effectiveness of intravenous parecoxib for tonsillectomy +/- adenoidectomy.2016https://dx.doi.org/10.1111/pan.13009
N.B. These documents automatically identified may not have been verified by the study sponsor.