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Prevention study for Emergence Delirium
Official title MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children
ClinicalTrials.gov ID: NCT05541276
What this study is testing
What is Melatonin?
Melatonin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for emergence delirium.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Postoperative agitation and emergence delirium describe a spectrum of symptoms of early postoperative negative behavior, in which the child experiences a variety of behavioral disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. The symptoms are common with a reported incidence of approximately 25%.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 6
You may be able to join if
- Patients aged 1-6 years
- Elective surgical procedure of en axpected duration of at least 30 minutes in general anesthesia maintained with sevoflurane
You likely can't join if
- Any known allergy or contraindication to study treatment or excipåients
- Current daily medication with melatonin
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Capital Region, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 6 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Capital Region, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.