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Sponsored by: |
County Durham and Darlington NHS Foundation Trust |
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Information provided by: | County Durham and Darlington NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT00765609 |
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.
Condition |
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Pain |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | To Evaluate the Paediatric Analgesia Slide, a New Device Developed to Assist Parents in Administering Paracetamol to Children at Home |
Estimated Enrollment: | 140 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Using the information distributed with over−the−counter medication (The Patient Information Leaflet or PIL)
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Paediatric Analgesia Slide (the new device)
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
parents administering analgesic medication to their children
Inclusion Criteria:
Exclusion Criteria:
Contact: Richard C Hixson, BM BS, FRCA | 0044 1325 743327 | Richard.Hixson@cddft.nhs.uk |
United Kingdom, England | |
County Durham and Darlington Acute Hospitals NHS Trust | |
Darlington, England, United Kingdom, DL3 6HX |
Principal Investigator: | Richard C Hixson, BM BS, FRCA | County Durham and Darlington Acute Hospitals NHS Trust |
Responsible Party: | County Durham and Darlington NHS Foundation Trust ( Dr Richard Hixson ) |
Study ID Numbers: | 08/H0904/93 |
Study First Received: | October 2, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00765609 |
Health Authority: | United Kingdom: Department of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: National Health Service; United Kingdom: Research Ethics Committee |
Paediatric Analgesic Prescribing Parents |
Pain Acetaminophen |