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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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England
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Darlington, England, Regno Unito, DL3 6HX
- County Durham and Darlington Acute Hospitals NHS Trust
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Solo caso
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Comparison of prescription accuracy using the information distributed with over-the-counter medication with the new device
Lasso di tempo: at data analysis
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at data analysis
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Ability of parents to interpret the prescribing information related to minimum dosage interval and maximum dosage frequency
Lasso di tempo: 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
Lasso di tempo: at data analysis
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at data analysis
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Richard C Hixson, BM BS, FRCA, County Durham and Darlington Acute Hospitals NHS Trust
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 08/H0904/93
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Dolore
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University of OklahomaThe Children's Hospital at OU Medical CenterCompletatoDolore addominale funzionale | Crisi falciforme | Pazienti seguiti dal Pain Team