Efficacy of Dexmedetomidine on Emergence Delirium in Children Undergoing Adenotonsillectomy: A Double-Blind Randomized Controlled Trial with Heart Rate Variability and Electroencephalography-Guided Anesthesia
This research study is investigating if a medication called dexmedetomidine can help prevent or lessen a common problem in children waking up from anaesthesia called 'emergence delirium.' This is when children can become confused, upset, or agitated after surgery, particularly following an operation to remove their tonsils and adenoids. Half of the children in the study will be given dexmedetomidine, and the other half will receive a salt-water solution, which acts as a comparison. The study will carefully check for signs of this distress and also look at pain levels, how long children stay in recovery, and whether there are any side effects. The aim is to see if dexmedetomidine makes a real difference in how children recover.
At a glance
What is this study about?
When children wake up after an operation where they've had anaesthetic, some can become quite confused, upset, and agitated. This is medically known as 'emergence delirium' and can be a distressing experience for both the child and their parents. This particular study is focusing on children who are having their tonsils and adenoids removed, which is a common operation in young people.
Researchers want to find out if a medicine called dexmedetomidine can help prevent or reduce this emergence delirium. They will compare it to a simple salt-water solution, which doesn't contain any active medicine, to see if dexmedetomidine actually makes a difference. This is a "Phase III" study, which means it's a key stage where researchers are trying to confirm if the new treatment works and is safe in a larger group of people, after earlier studies have shown promise.
The main thing the study will measure is whether children experience emergence delirium within the first 45 minutes of waking up. They will use a special scoring system to check for this. Researchers will also look at how much pain children feel, if they experience sickness after the operation, how long they stay in the recovery room, and overall parent satisfaction. They will also keep a close eye on any potential side effects from the medicine.
Key takeaways
- This study aims to reduce post-surgery confusion and distress in children.
- It tests a medicine called dexmedetomidine against a non-active saltwater solution.
- Children having tonsil and adenoid surgery are eligible.
- The study assesses how children wake up, their pain, and recovery time.
- It's a double-blind study, meaning no one knows who gets which treatment until the end.
Who may be eligible?
This study is open to all children, no matter their age or gender, who are having their tonsils and adenoids removed. The doctors will check your child's medical history to make sure they can safely take part in the study.
It's important that your child is generally healthy, apart from the reasons they need the tonsil and adenoid surgery. The study team will review all the details to ensure it's the right fit for your child.
They will also explain any other specific health conditions that might prevent your child from joining, making sure everyone involved is safe.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is my child scheduled for tonsil and adenoid removal surgery?
- Is my child generally healthy, aside from the reasons for surgery?
- Has my child's doctor confirmed there are no specific health issues preventing participation?
- Are we comfortable with my child potentially receiving a placebo (saltwater solution)?
What does participation involve?
If your child takes part in this study, they will have their operation to remove their tonsils and adenoids as planned. Before the operation, during the anaesthesia, your child will receive either the study medicine (dexmedetomidine) or a salt-water solution. Neither you, your child, nor the doctors caring for them will know which one they are receiving; this is called a 'double-blind' study. This helps ensure fair results.
After the operation, the medical team will carefully watch your child as they wake up. They will use different ways to check for any signs of confusion or distress (emergence delirium), measure pain levels using observations like facial expressions and body language, and record if they feel sick. They will also note how long your child stays in the recovery area. There will be checks at specific times after waking up – 15, 30, and 45 minutes – or whenever needed if your child shows signs of distress. The study will not involve any extra visits beyond the usual hospital stay for their tonsil and adenoid surgery.
Potential risks and benefits
Locations (1)
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Common questions
What is 'emergence delirium'?
It's when a child becomes confused, upset, or agitated as they wake up from anaesthesia after an operation.
What is dexmedetomidine?
It's a medicine used during anaesthesia that can help with anxiety and pain, and might prevent distress when waking up.
Will my child automatically get the study medicine?
No, half the children will get the study medicine and half will get a salt-water solution. It's decided randomly, like flipping a coin.
Will I know if my child received the medicine or the salt solution?
During the study, neither you nor the doctors will know. This is to ensure the results are unbiased.
Will this study add more time to my child's hospital stay?
No, the study assessments are done during their normal recovery time after their tonsil and adenoid surgery.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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