SLEEPS version 1.0

• Research type

  Research Study

• Full title

  SLEEPS: Safety profiLe, Efficacy and Equivalence in Paediatric intensive care Sedation

• IRAS ID

  1783

• Sponsor organisation

  University Hospitals Bristol NHS Foundation Trust

• Eudract number

  2008-000078-19

• ISRCTN Number

  02639863

• Research summary

  Clonidine is widely and increasingly used in Paediatric Intensive Care Units (PICU) for sedation. On the basis of very limited data, it appears to have improved characteristics over the most frequently used drug - midazolam, which is also more expensive. However clonidine has not be evaluated or licensed for this use. Through the trial we intend to find out whether midazolam and clonidine work equally well as sedatives or if one has less side effects than the other. The study aims to recruit 1000 children who have been admitted to the PICU and will take place at 12 different sites. Each patient who enters the trial will be given midazolam or clonidine (as is usually done) but neither the researchers nor the patients or their parents will know which treatment they are getting. Whilst the patient is in the study and being given the study medicine (clondine or midazolam), a validated scoring system called the COMFORT score will be used to measure the level of sedation in a child. The level of sedation will decide how much study drug needs to be given. All drugs that are given to the child during their stay in intensive care and also during the hospital stay after this will be recorded and the trial will also look at how well the different organs in the body are working. Once the study medicine has been stopped, the behaviour of patients will be observed so that any withdrawal from the study medicine is recorded and treated. There will also be a Pharmacodynamic/Pharmacokinetic and Phthalate Substudy which will be carried out in a smaller number of patients at a small number of centres that are taking part in the main study. This substudy will be carried out to check that the doses of a medicine that are being given to a patient are the most appropriate and to see if phthalate (a chemical used in the manufacture of plastics) leaks from medical equipment.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  08/H0706/111

• Date of REC Opinion

  11 Nov 2008

• REC opinion

  Favourable Opinion