To Evaluate the Paediatric Analgesia Slide
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|ClinicalTrials.gov Identifier: NCT00765609|
Recruitment Status : Unknown
Verified September 2008 by County Durham and Darlington NHS Foundation Trust.
Recruitment status was: Not yet recruiting
First Posted : October 3, 2008
Last Update Posted : October 3, 2008
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 or disease|
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|
|Estimated Enrollment :||140 participants|
|Official Title:||To Evaluate the Paediatric Analgesia Slide, a New Device Developed to Assist Parents in Administering Paracetamol to Children at Home|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||February 2009|
|Estimated Study Completion Date :||March 2009|
Using the information distributed with over-the-counter medication (The Patient Information Leaflet or PIL)
Paediatric Analgesia Slide (the new device)
- Comparison of prescription accuracy using the information distributed with over-the-counter medication with the new device [ Time Frame: at data analysis ]
- Ability of parents to interpret the prescribing information related to minimum dosage interval and maximum dosage frequency [ Time Frame: at data analysis ]
- To assess whether parents can accurately draw up the volume that they have stated in the primary objective [ Time Frame: at data analysis ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765609
|Contact: Richard C Hixson, BM BS, FRCA||0044 1325 743327||Richard.Hixson@cddft.nhs.uk|
|County Durham and Darlington Acute Hospitals NHS Trust|
|Darlington, England, United Kingdom, DL3 6HX|
|Contact: Richard C Hixson, BM BS FRCA 0044 1325 743327 Richard.Hixson@cddft.nhs.uk|
|Principal Investigator:||Richard C Hixson, BM BS, FRCA||County Durham and Darlington Acute Hospitals NHS Trust|