Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000997055
Ethics application status
Approved
Date submitted
20/05/2010
Date registered
17/11/2010
Date last updated
12/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Varying Body Weight on the Pharmacokinetics of Paracetamol in Children
Scientific title
Determining the Correct Paracetamol Dose for Children of Varying Body Weights
Secondary ID [1] 251829 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacokinetics of paracetamol in obesity 257431 0
Condition category
Condition code
Anaesthesiology 257575 257575 0 0
Pain management
Diet and Nutrition 257618 257618 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Measuring blood (from IV or finger-prick sources) and saliva paracetamol concentration in children following a prescribed dose of paracetamol in overweight and obese children. A maximum of 7 IV blood, 9 saliva and 3 finger-prick blood samples may be taken. Children who present to the Emergency Medicine Department at the Womens and Childrens Hospital who have been given a dose of paracetamol will be approached about participating in the study. Paracetamol will be given at a dose, schedule and route which is at the discretion of the medical staff - this study will not influence the treatment that participants recieve in any way (including the use of intra-venous cannula’s, which will only be used if they are inserted as part of normal medical care). Participants will be observed for no more than 6 hours after a dose of paracetamol. Patients will only be observed following a single dose.
Intervention code [1] 256558 0
Not applicable
Comparator / control treatment
There will be 3 groups of children recruited - one with BMI at or under the 25th percentile for age (as per CDC growth charts), one who are overweight or obese (as per Cole et al 2000), and another with normal BMI for their age (ie those that do not fall into either of the above definitions). All children who are recruited will have recieved paracetamol at a dose, schedule and route which is at the discretion of the medical staff - this study will not influence the treatment that participants recieve in any way. Participants will be observed for no more than 6 hours after a dose of paracetamol. Patients will only be observed following a single dose.
Control group
Active

Outcomes
Primary outcome [1] 258496 0
Determine and compare the pharmacokinetics (half-life, volume of distribution, clearance) of paracetamol in obese, overweight and children with a normal body mass index.
The saliva paracetamol concentration will be determined in each patient at each time point, and pharmacokinetic parameters will be determined by non-compartmental modelling and population pharmacokinetic modelling
Timepoint [1] 258496 0
Saliva samples may be taken pre-dose, then 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours after a dose. IV blood samples are scheduled for 0.5, 1, 1.5, 2, 3, 4 and 6 hours after a dose, and finger-prick samples for 1, 2 and 4 hours after a dose. Alterations in this schedule are allowed, but the precise time samples were taken must be recorded accurately.
Primary outcome [2] 258497 0
Compare the number of obese and overweight children whom achieve a therapeutically effective plasma paracetamol concentration (10-30mg/L) compared to the number of children with a normal body mass index
Timepoint [2] 258497 0
Using modelling techniques, we will be able to estimate what the drug concentration of any patient at any time (up to 6 hours after) a dose
Primary outcome [3] 258498 0
Determine the efficacy of paracetamol in achieving analgesia and/or antipyresis (ie reduction in pain as measured by routinely administered pain scores (eg visual analogue scales) or reduction in temperature (tympanic thermometry)) in obese, overweight and children with a normal body mass index
Timepoint [3] 258498 0
Using modelling techniques, we will be able to estimate what the pain scores and temperature of each patient at any time (up to 6 hours after) a dose
Secondary outcome [1] 264291 0
Using pharmacokinetic modelling, develop simple dosage strategies to ensure optimal therapeutic benefits of paracetamol in children of varying body weight
Timepoint [1] 264291 0
Using modelling techniques, we will be able to estimate what the drug concentration of any patient at any time (up to 6 hours after) a dose

Eligibility
Key inclusion criteria
Children who have been prescribed paracetamol by their treating doctor will be eligible for inclusion in the study.
Participants will have received one or more doses of paracetamol, the time of the last dose is precisely known.
Minimum age
1 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known abnormality in hepatic or renal function
Known chronic gastrointestinal dysfunction
Known mental health or intellectual disability

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
273
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257015 0
University
Name [1] 257015 0
University of South Australia
Country [1] 257015 0
Australia
Funding source category [2] 264862 0
Charities/Societies/Foundations
Name [2] 264862 0
Channel 7 Childrens Research Foundation
Country [2] 264862 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 256275 0
None
Name [1] 256275 0
Address [1] 256275 0
Country [1] 256275 0
Other collaborator category [1] 1292 0
Hospital
Name [1] 1292 0
Womens and Childrens Hospital
Address [1] 1292 0
72 King William Road
North Adelaide SA 5000
Country [1] 1292 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259034 0
Womens and Childrens Hospital
Ethics committee address [1] 259034 0
72 King William Road
North Adelaide SA 5006
Ethics committee country [1] 259034 0
Australia
Date submitted for ethics approval [1] 259034 0
21/08/2009
Approval date [1] 259034 0
05/05/2010
Ethics approval number [1] 259034 0
RED2207/9/12

Summary
Brief summary
The most appropriate dosage of the commonly used analgesic and antipyretic medication paracetamol has not been studied in overweight and obese children. Following a dose of paracetamol, we will measure the saliva and blood concentration (obtained from finger-prick or IV cannula) of paracetamol in a group of overweight and obese children, and compare the calculated pharmacokinetic parameters in the overweight/obese population to the normal BMI population, and determine if there are any differences. In addition, we will measure the efficacy of paracetamol in relieving pain and/or fever in each of these patient groups. A subsequant population pharmacokinetic/pharmacodynamic modelling analysis will allow us to simulate what doses are required to maintain overweight and obese children within a target therapeutic range of 10-30mg/L for the longest period of time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31201 0
Address 31201 0
Country 31201 0
Phone 31201 0
Fax 31201 0
Email 31201 0
Contact person for public queries
Name 14448 0
Dr Michael Wiese
Address 14448 0
University of South Australia
School of Pharmacy and Medical Sciences
GPO Box 2471
Adelaide 5001
Country 14448 0
Australia
Phone 14448 0
61 8 8302 2312
Fax 14448 0
Email 14448 0
michael.wiese@unisa.edu.au
Contact person for scientific queries
Name 5376 0
Dr Michael Wiese
Address 5376 0
University of South Australia
School of Pharmacy and Medical Sciences
GPO Box 2471
Adelaide 5001
Country 5376 0
Australia
Phone 5376 0
08 8302 2312
Fax 5376 0
Email 5376 0
michael.wiese@unisa.edu.au

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
EmbasePractical Challenges-Use of Paracetamol in Children and Youth Who are Overweight or Obese: A Narrative Review.2020https://dx.doi.org/10.1007/s40272-020-00417-z
N.B. These documents automatically identified may not have been verified by the study sponsor.