MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children
Launched by RIGSHOSPITALET, DENMARK · Sep 12, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of intravenous melatonin to help prevent postoperative agitation and emergence delirium in children. After surgery, some children may become very upset, confused, or restless as they wake up from anesthesia. This can happen to about 25% of children, and it can be quite distressing. By giving melatonin, a natural hormone that helps regulate sleep, during the surgery, researchers hope to see if it can reduce these behaviors and make the recovery process smoother for kids.
To participate in this study, children between the ages of 1 and 6 who are having a planned surgery that will last at least 30 minutes are eligible, as long as they do not have any known allergies to the treatment or are not currently taking melatonin. The trial is being conducted in a way that ensures fairness—neither the doctors nor the participants will know if they are receiving melatonin or a placebo (a harmless sugar pill that looks like the treatment). Families can expect to be closely monitored during and after the surgery to ensure the child's safety and comfort.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients aged 1-6 years
- • Elective surgical procedure of en axpected duration of at least 30 minutes in general anesthesia maintained with sevoflurane
- Exclusion Criteria:
- • Any known allergy or contraindication to study treatment or excipåients
- • Current daily medication with melatonin
About Rigshospitalet, Denmark
Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Copenhagen, Capital Region, Denmark
Patients applied
Trial Officials
Arash L Afshari, MD, PhD
Principal Investigator
Rigshospitalet, Denmark
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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