Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
Determining the Correct Paracetamol Dose for Children of Varying Body Weights
Query!
Secondary ID [1]
251829
0
nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pharmacokinetics of paracetamol in obesity
257431
0
Query!
Condition category
Condition code
Anaesthesiology
257575
257575
0
0
Query!
Pain management
Query!
Diet and Nutrition
257618
257618
0
0
Query!
Obesity
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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.
Query!
Intervention code [1]
256558
0
Not applicable
Query!
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.
Query!
Control group
Active
Query!
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
Query!
Assessment method [1]
258496
0
Query!
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.
Query!
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
Query!
Assessment method [2]
258497
0
Query!
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
Query!
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
Query!
Assessment method [3]
258498
0
Query!
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
Query!
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
Query!
Assessment method [1]
264291
0
Query!
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
Query!
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.
Query!
Minimum age
1
Years
Query!
Query!
Maximum age
18
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Known abnormality in hepatic or renal function
Known chronic gastrointestinal dysfunction
Known mental health or intellectual disability
Query!
Study design
Purpose
Natural history
Query!
Duration
Cross-sectional
Query!
Selection
Defined population
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
1/06/2010
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
273
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
257015
0
University
Query!
Name [1]
257015
0
University of South Australia
Query!
Address [1]
257015
0
GPO Box 2471
Adelaide SA 5001
Query!
Country [1]
257015
0
Australia
Query!
Funding source category [2]
264862
0
Charities/Societies/Foundations
Query!
Name [2]
264862
0
Channel 7 Childrens Research Foundation
Query!
Address [2]
264862
0
PO Box 2438, REGENCY PARK, SA 5942
Query!
Country [2]
264862
0
Australia
Query!
Primary sponsor type
University
Query!
Name
University of South Australia
Query!
Address
GPO Box 2471
Adelaide SA 5001
Query!
Country
Australia
Query!
Secondary sponsor category [1]
256275
0
None
Query!
Name [1]
256275
0
Query!
Address [1]
256275
0
Query!
Country [1]
256275
0
Query!
Other collaborator category [1]
1292
0
Hospital
Query!
Name [1]
1292
0
Womens and Childrens Hospital
Query!
Address [1]
1292
0
72 King William Road
North Adelaide SA 5000
Query!
Country [1]
1292
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
259034
0
Womens and Childrens Hospital
Query!
Ethics committee address [1]
259034
0
72 King William Road North Adelaide SA 5006
Query!
Ethics committee country [1]
259034
0
Australia
Query!
Date submitted for ethics approval [1]
259034
0
21/08/2009
Query!
Approval date [1]
259034
0
05/05/2010
Query!
Ethics approval number [1]
259034
0
RED2207/9/12
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
31201
0
Query!
Address
31201
0
Query!
Country
31201
0
Query!
Phone
31201
0
Query!
Fax
31201
0
Query!
Email
31201
0
Query!
Contact person for public queries
Name
14448
0
Dr Michael Wiese
Query!
Address
14448
0
University of South Australia
School of Pharmacy and Medical Sciences
GPO Box 2471
Adelaide 5001
Query!
Country
14448
0
Australia
Query!
Phone
14448
0
61 8 8302 2312
Query!
Fax
14448
0
Query!
Email
14448
0
[email protected]
Query!
Contact person for scientific queries
Name
5376
0
Dr Michael Wiese
Query!
Address
5376
0
University of South Australia
School of Pharmacy and Medical Sciences
GPO Box 2471
Adelaide 5001
Query!
Country
5376
0
Australia
Query!
Phone
5376
0
08 8302 2312
Query!
Fax
5376
0
Query!
Email
5376
0
[email protected]
Query!
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
Source
Title
Year of Publication
DOI
Embase
Practical Challenges-Use of Paracetamol in Children and Youth Who are Overweight or Obese: A Narrative Review.
2020
https://dx.doi.org/10.1007/s40272-020-00417-z
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF