Clinical Trials Directory

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UnknownNCT00765609

To Evaluate the Paediatric Analgesia Slide

To Evaluate the Paediatric Analgesia Slide, a New Device Developed to Assist Parents in Administering Paracetamol to Children at Home

Status
Unknown
Phase
Study type
Observational
Enrollment
140 (estimated)
Sponsor
County Durham and Darlington NHS Foundation Trust · Other Government
Sex
All
Age
Healthy volunteers
Accepted

Summary

The Paediatric Analgesia Slide is a device developed for parents. Its development follows research into the Paediatric Analgesia Wheel, a device intended for use by hospital doctors. Previous research has shown the benefit of using aids such as the Paediatric Analgesia Wheel when simulating prescribing to children in hospital. At present, it is unknown whether this concept can be extended to use by parents when administering paracetamol to their children at home.

Detailed description

Prescribing and administering drugs to children is difficult for both healthcare professionals and parents. The process is often performed poorly with under-dosing and over-dosing a major problem with sometimes fatal consequences. The British National Formulary for Children (BNFC), introduced in 2005, has given hospital and community prescribers with a valuable reference text. However, the comprehensive prescribing information presented in the BNFC and in the drug Summary of Product Characteristics is simplified in the Patient Information Leaflet (PIL) for interpretation by parents. When the PIL is analysed, it becomes apparent that the age-range regimens presented may result in under and over-dosing with large differences in the daily dose received by children depending on their age and weight. The Paediatric Analgesia Slide is a simple device presenting pre-calculated volume (and therefore dose) information for parents. It allows for age/weight specific doses to be given thus minimising the risk of under and over-dosing. It also addresses the deficiency of the prescribing information in the PIL related to over and under-weight children.

Conditions

Timeline

Start date
2008-12-01
Primary completion
2009-02-01
Completion
2009-03-01
First posted
2008-10-03
Last updated
2008-10-03

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT00765609. Inclusion in this directory is not an endorsement.