To Evaluate the Paediatric Analgesia Slide
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | October 2, 2008 | ||||
| Last Updated Date | October 2, 2008 | ||||
| Start Date ICMJE | December 2008 | ||||
| Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Comparison of prescription accuracy using the information distributed with over−the−counter medication with the new device [ Time Frame: at data analysis ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | To Evaluate the Paediatric Analgesia Slide | ||||
| Official Title ICMJE | To Evaluate the Paediatric Analgesia Slide, a New Device Developed to Assist Parents in Administering Paracetamol to Children at Home | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | parents administering analgesic medication to their children |
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| Condition ICMJE | Pain | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 140 | ||||
| Estimated Completion Date | March 2009 | ||||
| Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00765609 | ||||
| Other Study ID Numbers ICMJE | 08/H0904/93 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr Richard Hixson, County Durham and Darlington NHS Foundation Trust | ||||
| Study Sponsor ICMJE | County Durham and Darlington NHS Foundation Trust | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | County Durham and Darlington NHS Foundation Trust | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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