Skip to content

INTERNATIONAL STUDY ON MEDICINES ACCEPTABILITY IN THE PAEDIATRIC POPULATION Sub-study in the University Children´s Hospital Düsseldorf, Germany (DE)

INTERNATIONAL STUDY ON MEDICINES ACCEPTABILITY IN THE PAEDIATRIC POPULATION Sub-study in the University Children´s Hospital Düsseldorf, Germany (DE) - Accept18 DE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00021800
Enrollment
360
Registered
2020-08-21
Start date
2020-08-26
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Observation of all children and adolescents that take antibiotics and/or analgetics/antipyretics.

Interventions

Group 1: Patients between 0 and 18 years will be observed once when taking a Medicine (antibiotic, analgesic/antipyretic) for the firt time. In Addition medical staff will be observed when preparing t

Sponsors

Universitätsklinik Düsseldorf, Heinrich-Heine Universität Düsseldorf, Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: • 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.

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To create acceptability profiles of different medications.

Countries

Germany

Contacts

Public ContactViviane Klingmann

Universitätsklinik Düsseldorf, Heinrich-Heine Universität Düsseldorf, Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie

viviane.klingmann@med.uni-duesseldorf.de+49 (0)211 81 17687

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026