Effect of Varying Body Weight on the Pharmacokinetics of Paracetamol in Children
Determining the Correct Paracetamol Dose for Children of Varying Body Weights
University of South Australia
273 participants
Jun 1, 2010
Observational
Conditions
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.
Eligibility
Inclusion Criteria2
- 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.
Exclusion Criteria3
- Known abnormality in hepatic or renal function
- Known chronic gastrointestinal dysfunction
- Known mental health or intellectual disability
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Interventions
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.
Locations(1)
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ACTRN12610000997055