The PREVENT AGITATION Trial II - Children ≤1 Year

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-25

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Emergence Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Part A: Open-label pharmacokinetic part (n =16) Part B: Randomized placebo-controlled part (n =320)

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Clonidine

Participants receive Clonidine solution for injection, 3 microg/kg, administered intravenously once over 2 minutes approximately 20 minutes before end of procedure. Injection is administered from a dilated solution of Clonidine 15 microg/mL (ie., 0.2 mL/kg).

Group Type EXPERIMENTAL

Clonidine

Intervention Type DRUG

Clonidine injection 3 mcg/kg once

Placebo

Participants receive Sodium Chloride isotonic (9mg/mL) solution for injection administered intravenously once over 2 minutes approximately 20 minutes before end of procedure. Dosage is administered according to weight: 0.2 mL/kg.

Group Type PLACEBO_COMPARATOR

Sodium chloride

Intervention Type DRUG

Sodium chloride 0.9 % injection 0.2 mL/kg once

Interventions

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Clonidine

Clonidine injection 3 mcg/kg once

Intervention Type DRUG

Sodium chloride

Sodium chloride 0.9 % injection 0.2 mL/kg once

Intervention Type DRUG

Other Intervention Names

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Catapresan Catapres Normal saline

Eligibility Criteria

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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)

Minimum Eligible Age

3 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No