Most critically ill children admitted to Neonatal Intensive Care Units or Paediatric Intensive Care Units require pain medication and sedatives to reduce anxiety and distress and to help facilitate treatments and recovery. To date, this is commonly achieved by using medicines not licensed for children (called “off-label” use), risking inefficient treatment and significant side effects. Appropriately designed paediatric studies are therefore needed to develop age appropriate, safe and efficacious treatments for children.
Clonidine has been a well-known drug for decades. It offers antihypertensive, soothing and sedative effects but is presently only authorised for use in adults, even if it is commonly used in paediatric patients. The CloSed project, a 5-year research project funded by the European Union, aims to develop a new formulation of clonidine specifically designed for children under the age of 18 and to study clonidine as a sedative drug in this patient group. At the end of the project, an authorisation for its use in the paediatric population is envisaged and international guidelines on sedative dosing regimens for neonates, children and adolescents will be provided.