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Content archived on 2024-06-18

Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit

Objective

The majority of critically ill children admitted to Paediatric Intensive Care Units (PICU) will require sedation
and analgesia which is commonly achieved with a combination of an benzodiazepine and an opioid. However,
these agents have a significant side-effect profile, including tolerance, withdrawal and respiratory/circulatory
depression. Clonidine is commonly used for sedation in PICU and recommended by guidelines in various
countries although there is a lack of evidence regarding it safety and efficacy in this setting. The need for safety
and efficacy data as well as an age appropriate formulation for clonidine has been realised and clonidine is
included in the EMA “Revised Priority List for Studies into Off-patent Medicinal Products”. Thus this proposal
addresses an important paediatric therapeutic need. It is designed to fullfill the requirements for most ethical
research in the paediatric population considering risk minimisation for patients, avoiding unnecessary studies and
make use of already available data as outlined in the Paediatric Regulation (EC) No 1901/2006. The objectives
of this project are a) to develop an age appropriate formulation of clonidine suitable for sedation of children in
PICU b) to conduct a randomised, phase III, double-blind, active-controlled parallel group clinical trial of clonidine
vs midazolam in patients from birth to 18 years to establish the efficacy and safety, including long-term outcomes
and dose-dependent effects of clonidine and c) to establish an European consensus guideline for sedion of
critically ill children. The ultimate goal is to use these data and to apply for a PUMA. On this basis a Paediatric
Investigation Plan (PIP) has been approved by the EMA in February 2013 and is reflected in the work plan of
CloSed. The project will increase the availability of paediatric medicines, foster the conduct of clinical trials in
children and establish international paediatric research collaborations.

Fields of science (EuroSciVoc)

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Programme(s)

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Topic(s)

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

FP7-HEALTH-2013-INNOVATION-1
See other projects for this call

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

CP-FP - Small or medium-scale focused research project

Coordinator

UNIVERSITATSKLINIKUM ERLANGEN
EU contribution
€ 1 803 610,55
Address
MAXIMILIANSPLATZ 2
91054 ERLANGEN
Germany

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Region
Bayern Mittelfranken Erlangen, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

No data

Participants (11)

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