None listed
Conditions
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
Interventions
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 obtaine
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.
Sponsors
Dr. Elsa Taylor
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
4 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
Group 1- Patients undergoing tonsillectomy with or without adnenoidectomy Group2 - Patients undergoing appendicectomy or repair of fractures
Exclusion criteria
EXCLUSION CRITERIA IN BOTH GROUPS Patients with hepatic, renal or cardiac sequelae. Learning difficulties. Coagulation defects. Allergy to NSAIDS.
Outcome results
None listed