The PREVENT AGITATION Trial II - Children ≤1 Year
ConditionEmergence Delirium
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age3-12
SponsorRigshospitalet, Denmark
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Clonidine
DrugClonidine injection 3 mcg/kg once
Sodium chloride
DrugSodium chloride 0.9 % injection 0.2 mL/kg once
Treatment groups
336 Participants
are divided into 2 treatment groupsGroup A: ClonidineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of emergence agitation during stay in postanaesthetic care unit (PACU)
Participants will be assessed on Watcha scale (1=calm, 4=agitated and thrashing around) every 15 minutes from arrival to PACU till discharge therefrom. Emergence agitation is defined dichotomously as Yes/No, Yes being if any Watcha score \>2.
Time frame
From admission to PACU to discharge from PACU, up to app. 4 hours. Emergence agitation is considered present ("Yes"), if Watcha score>2 at ANY time point within the given time frame.2
Compartmental clearance for pharmacokinetic profiling.
Pharmacokinetic sampling will be performed in 1 mL EDTA tubes and analysed for clonidine plasma concentration in migrog/L
Time frame
Samples will be collected at baseline and at 5, 15, 30, and 60 minutes post dosage and just prior prior to removal of iv-access ie., at latest 120-240 min post dosage.3
Volume of distribution for pharmacokinetic profiling.
Pharmacokinetic sampling will be performed in 1 mL EDTA tubes and analysed for clonidine plasma concentration in migrog/L
Time frame
Samples will be collected at baseline and at 5, 15, 30, and 60 minutes post dosage and just prior prior to removal of iv-access ie., at latest 120-240 min post dosage.4
T1/2 for pharmacokinetic profiling.
Pharmacokinetic sampling will be performed in 1 mL EDTA tubes and analysed for clonidine plasma concentration in migrog/L
Time frame
Samples will be collected at baseline and at 5, 15, 30, and 60 minutes post dosage and just prior prior to removal of iv-access ie., at latest 120-240 min post dosage.Secondary outcomes
1
Proportion of participants with postoperative pain
Participants will be assessed on Faces Legs Activity Cry Consolability (FLACC) scale every 15 minutes from arrival to PACU till discharge therefrom. Postoperative pain is defined as any FLACC score \> 3 during PACU stay.
Time frame
From admission to PACU to discharge from PACU, up to app. 4 hours.2
Proportion of participants with Postoperative Nausea and Vomiting (PONV)
Participants will be assessed for PONV every 15 minutes during PACU stay. No validated scale for assessment of PONV exists in this age group and PONV will be assessed by dichotomously as "Yes" or "No". While vomiting is obvious, nausea may be considered if participant refuses to eat and other causes are ruled out.
Time frame
From admission to PACU to discharge from PACU, up to app. 4 hours.3
Safety and tolerability of clonidine in infants 3-12 months of age: proportion of participants with adverse events of clinical interest
Composite outcome combining as assessed by investigator for each participant any clinically relevant hypotension (ie., necessitating intervention), clinically relevant bradycardia (ie., necessitating intervention), clinically relevant apnoea (ie., unexplained cessation of breathing for 20 seconds or longer, or a shorter respiratory pause associated with bradycardia, cyanosis, and/or marked hypotonia).
Time frame
From administration of intervention through end of anaesthesia and PACU stay (up to app. 4 hours). Supplemental Adverse Event follow-up at 24 hours, 48 hours in case of ongoing adverse events and at 30 days post-intervention.4
Mean sedation level in PACU
Participants will be assessed for alertness on the University of Michigan Sedation Scale (UMSS) every 15 minutes during PACU stay.
Time frame
From admission to PACU to discharge from PACU, up to app. 4 hours.Sponsors and contacts
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Source ClinicalTrials.gov