The PREVENT AGITATION Trial II - Children 1 Year

  • STATUS
    Recruiting
  • End date
    Jan 31, 2024
  • participants needed
    336
  • sponsor
    Rigshospitalet, Denmark
Updated on 20 November 2021

Summary

Emergence agitation is a clinical condition in which the child experiences a variety of behavioural disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. Emergence agitation is a common challenge in children with a reported incidence of approximately 25% ranging from 10 to 80 %. Clonidine is often used off-label in paediatric anaesthesia e.g. sedation in the intensive care unit, prevention of withdrawal symptoms after long-term sedation, as premedication before induction of anaesthesia or as treatment/prevention of emergence agitation. The study is designed as a randomised, placebo-controlled clinical trial evaluating efficacy and safety of a single dose of intraoperative clonidine in children 3-12 months, including pharmacokinetics.

Details
Condition Emergence Delirium
Treatment clonidine, Sodium chloride
Clinical Study IdentifierNCT05091242
SponsorRigshospitalet, Denmark
Last Modified on20 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Paediatric patients (male and female), aged 3- 12 months
Scheduled general anaesthesia with sevoflurane and opioid. Induction with propofol is optional
The legally acceptable representative for the study participant provides written informed consent/assent for the trial

Exclusion Criteria

ASA >2
Cardiac, neuro and trauma surgery
Ex-premature (<37 weeks) Premedication with clonidine
Intubated prior to scheduled anaesthesia or is expected to require intubation after the procedure
Critical illness incl. hemodynamic instability (inotropic drugs needed)
Bleeding requiring transfusion prior to scheduled anaesthesia
Planned for a postoperative nurse-controlled analgesia pump including a continuous infusion of opioid
Malignant disease
Cardiac disease incl. arrhythmia
Chronic lung disease that may influence study results or study participation in the opinion of the Investigator or may comprise safety and well-being of the patient
Mental retardation
Neurological disease including symptoms similar to emergence agitation
Has or is suspected of having a family or personal history of malignant hyperthermia
Has or is suspected of having an allergy to study treatment or its excipients
Any condition that can in opinion of the Investigator, deteriorate safety and well-being of the patients or interfere with pharmacokinetic data
Positive Covid-19 test or clinical suspicion of Covid-19 (according to current local guidelines)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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