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Effect of Varying Body Weight on the Pharmacokinetics of Paracetamol in Children

Determining the Correct Paracetamol Dose for Children of Varying Body Weights

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12610000997055
Enrollment
273
Registered
2010-11-17
Start date
2010-06-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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 rou

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.

Sponsors

University of South Australia
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years
Healthy volunteers
No

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.

Exclusion criteria

Known abnormality in hepatic or renal function Known chronic gastrointestinal dysfunction Known mental health or intellectual disability

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026