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To Evaluate the Paediatric Analgesia Slide

NCT ID: NCT00765609

Last Updated: 2008-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-03-31

Brief Summary

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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

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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

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Pain

Keywords

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Paediatric Analgesic Prescribing Parents

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Using the information distributed with over-the-counter medication (The Patient Information Leaflet or PIL)

No interventions assigned to this group

2

Paediatric Analgesia Slide (the new device)

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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County Durham and Darlington NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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County Durham and Darlington NHS Foundation Trust

Principal Investigators

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Richard C Hixson, BM BS, FRCA

Role: PRINCIPAL_INVESTIGATOR

County Durham and Darlington Acute Hospitals NHS Trust

Locations

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County Durham and Darlington Acute Hospitals NHS Trust

Darlington, England, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Richard C Hixson, BM BS, FRCA

Role: CONTACT

Phone: 0044 1325 743327

Email: [email protected]

Facility Contacts

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Richard C Hixson, BM BS FRCA

Role: primary

Other Identifiers

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08/H0904/93

Identifier Type: -

Identifier Source: org_study_id