To Evaluate the Paediatric Analgesia Slide

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00765609
• Other study ID #: 08/H0904/93
• Status: Not yet recruiting
• Phase: N/A
• First received: October 2, 2008
• Last updated: October 2, 2008
• Start date: December 2008
• Est. completion date: March 2009

Study information

• Verified date: September 2008
• Source: County Durham and Darlington NHS Foundation Trust
• Contact: Richard C Hixson, BM BS, FRCA
• Phone: 0044 1325 743327
• Email: Richard.Hixson[@]cddft.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Department of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
United Kingdom	County Durham and Darlington Acute Hospitals NHS Trust	Darlington	England

Sponsors (1)

Lead Sponsor	Collaborator
County Durham and Darlington NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of prescription accuracy using the information distributed with over-the-counter medication with the new device		at data analysis	Yes
Secondary	Ability of parents to interpret the prescribing information related to minimum dosage interval and maximum dosage frequency		at data analysis	Yes
Secondary	To assess whether parents can accurately draw up the volume that they have stated in the primary objective		at data analysis	Yes