This study involves children who are critically ill and need to be on a breathing machine in a pediatric intensive care unit. The study focuses on a condition called delirium, which is a state of confusion and changes in thinking that can happen to children who are very sick and receiving intensive care. The study will compare two different medications used for sedation, which means keeping children calm and comfortable while they are on the breathing machine. One medication is dexmedetomidine, which will be given as a continuous infusion through a vein. The other medication is midazolam, which belongs to a group of medicines called benzodiazepines and is also given through a vein. The purpose of the study is to find out if using dexmedetomidine can reduce the number of children who develop delirium while they are in the pediatric intensive care unit.
Children in the study will be between one month and seventeen and a half years old and will need to be on a breathing machine for more than twelve hours. They will receive one of the two sedation medications as their main treatment to keep them comfortable. Throughout their stay in the intensive care unit, doctors and nurses will regularly check for signs of delirium using a special rating scale. They will also monitor how well the sedation is working, whether the child is too sleepy or not sleepy enough, and any side effects that might occur. The study will track how long children need to stay on the breathing machine, how long they stay in the intensive care unit, and how long they remain in the hospital overall.
The study will also look at other important outcomes, including how much sedation and pain medication each child needs, whether children experience withdrawal symptoms when medications are stopped, and whether any complications occur such as low blood pressure, slow heart rate, or accidental removal of breathing tubes or other medical devices. Doctors will record if children need additional medications to treat delirium, if they need brain imaging or special tests to check brain activity, and whether they need to be put back on the breathing machine after it is removed. The study will continue to follow children for three months to understand the full impact of the different sedation approaches on their recovery and the costs of their care.



France