RecruitingACTRN12610000997055

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

Determining the Correct Paracetamol Dose for Children of Varying Body Weights

Sponsor

University of South Australia

Enrollment

273 participants

Start Date

Jun 1, 2010

Study Type

Observational

Conditions

Pharmacokinetics of paracetamol in obesity

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

Sex: Both males and femalesMin Age: 1 YearsMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at how the painkiller paracetamol (Tylenol/Panadol) is processed by the body in children who are overweight or obese, compared with children of a healthy weight. Researchers will measure paracetamol levels in saliva and blood after children receive the medication as prescribed by their doctor, to figure out whether the current recommended doses are appropriate for all body sizes. You may be eligible if: - Your child is between 1 and 18 years old - Your child has been prescribed paracetamol by their treating doctor - The time of the last dose of paracetamol is precisely known You may NOT be eligible if: - Your child has known liver or kidney problems - Your child has a known chronic gut condition - Your child has a known mental health condition or intellectual disability Talk to your doctor about whether this trial might be right for you.

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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)

Australia

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ACTRN12610000997055