MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children
Recruiting
Phase 3
Interventional Study
Emergence Delirium
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 – 6
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 400 (estimated)
- Sponsor
- Rigshospitalet, Denmark · Other
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About This Trial
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%. Some clinical trials have studied the effect of pr…
Trial Locations
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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 wit…
Contacts