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To Evaluate the Paediatric Analgesia Slide

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NHS Trust

Status

Unknown

Conditions

Pain

Study type

Observational

Funder types

Other

Identifiers

NCT00765609
08/H0904/93

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Any parent accompanying their child who is aged between 1 and 13 years old who is attending a hospital in County Durham and Darlington Acute Hospitals NHS Trust

Exclusion criteria

  • Those who have professional knowledge of prescribing or dispensing medicine (e.g. as a doctor, nurse or pharmacist);
  • Those who already have been given advice on the correct dose of paracetamol for their child as part of the current hospital episode;
  • Those who's child is under 1 year or over 13 years old and;
  • Those who have participated in this research before.

Trial design

140 participants in 2 patient groups

1
Description:
Using the information distributed with over-the-counter medication (The Patient Information Leaflet or PIL)
2
Description:
Paediatric Analgesia Slide (the new device)

Trial contacts and locations

1

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Central trial contact

Richard C Hixson, BM BS, FRCA

Data sourced from clinicaltrials.gov

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