In short
This article provides information about ongoing clinical trials investigating treatments for neurological complications that occur after anesthesia, particularly emergence delirium and agitation in children following surgery. Currently, there is one clinical trial testing whether melatonin can help prevent confusion and distress when children wake up from general anesthesia.
Clinical trial locations
Evaluating the effects of intravenous melatonin for preventing agitation and emergence delirium in children undergoing elective surgery
This clinical trial is investigating whether melatonin, a substance that naturally occurs in the body and helps regulate sleep patterns, can prevent a distressing condition called emergence delirium in children after surgery. Emergence delirium is a temporary state where children become confused, restless, and agitated when waking up from anesthesia. The condition is particularly common in young children and can be upsetting for both the child and their family.
Who can participate:
- Children between 1 and 6 years old
- Scheduled for planned surgery lasting at least 30 minutes under general anesthesia
- Both boys and girls are welcome to participate
- Must be healthy enough for their scheduled surgery
- Parent or legal guardian must provide consent
Who cannot participate:
- Children younger than 2 years or older than 18 years
- Children with known allergies to melatonin
- Those with serious medical conditions affecting the heart, lungs, liver, or kidneys
- Children with sleep disorders or currently taking sleep medications
- Those with neurological disorders or developmental delays
- Children needing emergency surgery
- Those taking medications that might interact with melatonin
- Children with psychiatric conditions requiring medication
- Those who participated in another clinical trial within the past 30 days
What the trial involves:
During surgery, while your child is under general anesthesia, they will receive either melatonin or a placebo (sodium chloride solution) through an intravenous line. This is what researchers call a blinded study, meaning neither the medical staff nor the families will know which treatment is being given. This design helps ensure that the results are accurate and unbiased.
After surgery, medical staff will carefully observe your child as they wake up from anesthesia. They will monitor for any signs of confusion, agitation, or distress. The team will also track how much pain medication is needed during recovery and watch for any side effects from the treatment.
The investigational drug:
Melatonin is a hormone that the body produces naturally to regulate sleep and wake cycles. In this trial, it is given directly into the bloodstream during surgery rather than as an oral medication. The study explores whether this approach can help children have a calmer and more comfortable recovery from anesthesia by preventing the confusion and agitation that sometimes occurs when waking up from general anesthesia.
Study goal:
The main purpose of this trial is to determine whether intravenous melatonin can safely and effectively prevent emergence delirium in children undergoing surgery. This condition typically occurs within the first 30 minutes after waking from anesthesia and usually resolves on its own as the anesthesia wears off. However, it can be distressing for children and their families. If melatonin proves effective, it could offer a new way to help children have a smoother recovery experience after surgery.
Summary
Currently, there is one clinical trial addressing neurological complications from anesthesia, specifically focusing on emergence delirium in children. This trial is being conducted in Denmark and represents a novel approach to managing post-surgical behavioral disturbances in pediatric patients. The study focuses on melatonin as a potential preventive treatment, which differs from traditional sedatives typically used in such situations. The trial is limited to young children between 1 and 6 years old undergoing planned surgical procedures, reflecting the higher incidence of emergence delirium in this age group. Parents interested in this trial should discuss participation with their child's surgical team to determine if their child meets the eligibility criteria.
