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

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.

Study Overview

• Status: Unknown
• Conditions: Pain

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.

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Darlington, England, United Kingdom, DL3 6HX
      • County Durham and Darlington Acute Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

parents administering analgesic medication to their children

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of prescription accuracy using the information distributed with over-the-counter medication with the new device	at data analysis

Secondary Outcome Measures

Outcome Measure	Time Frame
Ability of parents to interpret the prescribing information related to minimum dosage interval and maximum dosage frequency	at data analysis
To assess whether parents can accurately draw up the volume that they have stated in the primary objective	at data analysis

Collaborators and Investigators

• Sponsor: County Durham and Darlington NHS Foundation Trust
• Investigators: Principal Investigator: Richard C Hixson, BM BS, FRCA, County Durham and Darlington Acute Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Anticipated): February 1, 2009
• Study Completion (Anticipated): March 1, 2009

Study Registration Dates

• First Submitted: October 2, 2008
• First Submitted That Met QC Criteria: October 2, 2008
• First Posted (Estimate): October 3, 2008

Study Record Updates

• Last Update Posted (Estimate): October 3, 2008
• Last Update Submitted That Met QC Criteria: October 2, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Parents; Prescribing; Analgesic; Paediatric
• Other Study ID Numbers: 08/H0904/93