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Study on Preventing Agitation After Anesthesia in Children Aged 1 Year or Younger Using Clonidine Hydrochloride and Sodium Chloride

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as emergence agitation, which can occur in children after they wake up from anesthesia. The study aims to explore the effectiveness of a medication called clonidine hydrochloride in preventing this condition. Clonidine hydrochloride is administered as a solution for injection during surgery. Another substance, sodium chloride, is also used in the study as a solution for injection.

The purpose of the study is to evaluate how well clonidine hydrochloride works in preventing emergence agitation in children who are one year old or younger. The study will also look at how the body processes clonidine hydrochloride when given as a single dose during surgery. Participants in the study will receive either clonidine hydrochloride or a placebo while under general anesthesia, which is a type of medication that makes them sleep during surgery.

Throughout the study, researchers will monitor the children for signs of emergence agitation and any side effects. They will also assess the need for additional pain relief after surgery. The study will help to better understand the potential benefits and safety of using clonidine hydrochloride in young children undergoing surgery. The trial is expected to continue until early 2026.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
The trial is designed for children aged 3 to 12 months who are scheduled for general anaesthesia with sevoflurane and an opioid. Induction with propofol is optional.
A legally acceptable representative must provide written informed consent for participation in the trial.
Step 2
Administration of medication
During the operation, a single dose of clonidine hydrochloride is administered as a solution for injection to prevent agitation after anaesthesia.
The medication is given intraoperatively, meaning it is administered during the surgery.
Step 3
Monitoring after anaesthesia
After the operation, the child is monitored in the postanaesthetic care unit.
The level of agitation is measured using the Watcha score, where 1 indicates calm and 4 indicates agitated and thrashing around. A score greater than 2 indicates significant agitation.
Step 4
Assessment of additional needs
The amount of additional opioid needed for postoperative pain is calculated as morphine equivalents.
Nausea and vomiting are assessed. Vomiting is obvious, while nausea may be considered present if the child refuses to eat and other causes are ruled out.
Step 5
Evaluation of side effects
The trial evaluates the occurrence of clinically relevant hypotension, bradycardia, and apnoea.
These are monitored to ensure the safety and well-being of the child during the trial.

Who can join the trial?

3 criteria

Children who are between the ages of 3 months and 12 months.
Children who are scheduled to have general anesthesia using a medicine called sevoflurane and a type of pain medicine called an opioid. The start of anesthesia with a medicine called propofol is optional.
The child's parent or legal guardian must agree to the study and sign a form giving their permission for the child to participate.

Who cannot join the trial?

9 criteria

Patients who have a known allergy or sensitivity to clonidine, which is a medication used in this study.
Patients with a history of severe heart problems, as clonidine can affect heart function.
Patients who are currently taking medications that might interact negatively with clonidine.
Patients with uncontrolled high blood pressure, as clonidine can lower blood pressure.
Patients with severe liver or kidney disease, as these organs help process medications in the body.
Patients who are pregnant or breastfeeding, to avoid any potential risks to the baby.
Patients who have participated in another clinical trial recently, to ensure accurate study results.
Patients with a history of severe mental health disorders, as clonidine can affect mood and behavior.
Patients who are unable to follow the study procedures or attend follow-up visits.

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Rigshospitalet
Copenhagen, Denmark

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Investigated drugs

Clonidine is being studied in this trial to see if it can help prevent agitation in children who are 1 year old or younger after they wake up from surgery. The trial is also looking at how the body processes clonidine when it is given as a single dose during surgery.

What is already known about the treatment

Clonidine – Clonidine is administered as a single dose during surgery, typically through an intravenous route. It is currently being studied in clinical trials for its effectiveness in preventing emergence agitation in children aged one year or younger after anesthesia. The medication is primarily used to manage high blood pressure and certain pain conditions, but in this trial, it is being evaluated for its calming effects post-surgery. Clonidine works by stimulating specific receptors in the brain, which helps to reduce nerve signals that can cause agitation. It is classified as an alpha-2 adrenergic agonist, which means it helps to lower blood pressure and has sedative properties.

Investigated diseases

Emergence Agitation – This condition occurs after a person wakes up from anesthesia, often seen in children. It is characterized by confusion, restlessness, and sometimes aggressive behavior. The individual may appear disoriented and may thrash around or be difficult to calm. This agitation typically happens during the recovery phase in the post-anesthetic care unit. The severity can vary, with some individuals experiencing mild symptoms while others may have more intense reactions. The exact cause is not fully understood, but it is believed to be related to the effects of anesthesia on the brain.