- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
England
-
Darlington, England, Det Forenede Kongerige, DL3 6HX
- County Durham and Darlington Acute Hospitals NHS Trust
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
---|
1
Using the information distributed with over-the-counter medication (The Patient Information Leaflet or PIL)
|
2
Paediatric Analgesia Slide (the new device)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Comparison of prescription accuracy using the information distributed with over-the-counter medication with the new device
Tidsramme: at data analysis
|
at data analysis
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Ability of parents to interpret the prescribing information related to minimum dosage interval and maximum dosage frequency
Tidsramme: at data analysis
|
at data analysis
|
To assess whether parents can accurately draw up the volume that they have stated in the primary objective
Tidsramme: at data analysis
|
at data analysis
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Richard C Hixson, BM BS, FRCA, County Durham and Darlington Acute Hospitals NHS Trust
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 08/H0904/93
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