- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00765609
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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England
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Darlington, England, Reino Unido, DL3 6HX
- County Durham and Darlington Acute Hospitals NHS Trust
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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1
Using the information distributed with over-the-counter medication (The Patient Information Leaflet or PIL)
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2
Paediatric Analgesia Slide (the new device)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Comparison of prescription accuracy using the information distributed with over-the-counter medication with the new device
Periodo de tiempo: at data analysis
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at data analysis
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Ability of parents to interpret the prescribing information related to minimum dosage interval and maximum dosage frequency
Periodo de tiempo: at data analysis
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at data analysis
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To assess whether parents can accurately draw up the volume that they have stated in the primary objective
Periodo de tiempo: at data analysis
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at data analysis
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Richard C Hixson, BM BS, FRCA, County Durham and Darlington Acute Hospitals NHS Trust
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 08/H0904/93
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