INTERNATIONAL STUDY ON MEDICINES ACCEPTABILITY IN THE PAEDIATRIC POPULATIONSub-study in the University Children´s Hospital Düsseldorf, Germany (DE)
- Conditions
- Observation of all children and adolescents that take antibiotics and/or analgetics/antipyretics.
- Registration Number
- DRKS00021800
- Lead Sponsor
- niversitätsklinik Düsseldorf, Heinrich-Heine Universität Düsseldorf, Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 360
• Patients < 18 years of age
• Receiving any medicine by any route of administration, including those delivered via cannula provided that the cannula is inserted at the time of medicine administration.
• Written informed consent from both parents or the legal guardian. They must understand the contents of the informed consent form, requirements of the study and have had an opportunity to review questions with a trained member of the site study team. It is not necessary that the second parent is personally present. The second informed consent can be obtained by telephone in presence of an independent witness.
• Verbal or written age appropriate assent from the patient if able to give.
• No limitations of nationalities, demographics, socio-economic groups, ethnic groups.
• All participants contributing to the study must be able to read and understand German.
• Age >18 years of age
• Parent/carer unable to read and/or understand the study information leaflet
• Receiving intravenous medication where the intravenous device is already in situ – part of the acceptability will consider the insertion of such a device
• Written consent not obtained from both parents
• The patient is deemed unsuitable at the discretion of the investigator
• Child participant does not assent verbally to participating in the study
• Parent/carer or participant unable or unwilling to give consent
• The treating clinical team feel there is pronounced family distress or child protection intervention that would make it inappropriate to approach the family to take part in the study
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The objective of this study is to increase the knowledge on factors affecting medicine acceptability in the paediatric population, using a standardized assessment tool: CAST - ClinSearch Acceptability Score Test®.
- Secondary Outcome Measures
Name Time Method To create acceptability profiles of different medications.