Clinical trial NCT03799783
Conditions: Procedural Sedation Behavior Disorders
Keywords: dexmedetomidine sedation
Sponsor: Azienda Ospedaliera di Padova
Start date: 2018-03-01; Completion date: 2019-09-28
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Children's compliance during diagnostic or therapeutic procedures is a challenge, often requiring the use of sedative and/or analgesic drugs.

Electroencephalogram (EEG) needs stillness for a medium-long period but, at the same time, the use of any drug for sedation may affect the exam through an interference with EEG waves. Dexmedetomidine is a selective ∝2-adrenergic agonist with sedative and anxiolytic properties, with a long effect and which does not alter EEG pattern.

The aim of this interventional study is to evaluate the effectiveness, safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative.

Children affected by behavioral disorders and requiring sedation to perform EEG were considered. The protocol establishes to administer IV dexmedetomidine (loading dose and continued infusion) to reach a targeted level of sedation (Pediatric Sedation State Scale = 2). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during and after procedure until the offset.

Detailed description:
Compliance during diagnostic or therapeutic procedures is a very frequent challenge in children. Procedural sedation and analgesia represents an effective answer to this problem. Electroencephalogram (EEG) is a procedure which needs stillness for a medium-long period. Whereas the majority of children carry out this procedure without sedation, patients with behavioral problems, who frequently need to rule out the presence of seizures as associated symptoms or different disease, often show an insufficient compliance. Sedative drugs usually interfere with EEG cerebral waves pattern, so they can not be used. Dexmedetomidine is a selective ∝2-adrenergic agonist with prevalent sedative and anxiolytic properties, with a long effect and which does not alter EEG pattern.

The aim of this interventional study is to evaluate effectiveness, safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative.

Children referred to the Pediatric Neurology Department of the Pediatric Hospital of Padova and required sedation to perform EEG were considered in the study.

The protocol establishes to administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete. The loading dose can be repeated up to two times, if needed, to achieve the targeted level of Pediatric Sedation State Scale (PSSS) of 2 (quiet, asleep or awake, not moving during procedure, and no frown or brow furrow indicating pain or anxiety, no verbalization of any complaint). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during and after procedure until the complete awake of the patient. The quality of the EEG pattern was also evaluated. Occurrence and type of adverse events are registered during this period. Finally, the caregivers' opinion about the quality of the sedation and the presence of any sleep disturbance at home during the next 12 hours after the procedure were considered.

Arms: arm 1: 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
Interventions: intervention 1: dexmedetomidine
Intervention descriptions: intervention 1: To administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete

Protocol documents:
Prot_SAP_000.pdf: 
THE USE OF DEXMEDETOMIDINE FOR EEG SEDATION IN CHILDREN WITH 
BEHAVIORAL DISORDERS  
20/2/2020 
NCT03799783 protocol 
Background 
Diagnostic and therapeutic procedures are often difficult to perform in pediatric population due to a low 
compliance. Electroencephalogram (EEG) recording represents a particular challenge. The child should be 
quiet for a medium-long time and an EEG registration during spontaneous sleep is often necessary for a 
complete assessment. Even if a dedicated environment and adequate preparation of both child and parents 
make it usually easy to be successfully performed, it could become difficult in children affected by 
behavioural disturbance, such as autism spectrum dis- order (ASD). It's known that children with ASD have 
a higher risk of epilepsy compared with the general population,so they more frequently need EEG recordings 
both while awake and while asleep. In such cases, the use of conventional sedative and hypno-inducing 
drugs to obtain an EEG both in wakefulness and sleep is definitely limited, taking into account that the 
majority of drugs modifies EEG pattern.In this context, Dexmedetomidine could represent an alternative 
solution. It is an emerging long-lasting α-2 agonist anxiolytic and sedative drug with analgesic effects,able to 
induce a para-physiologic sleep status with no significant interference on EEG patternsand possible but 
infrequent cardiovascular side effects (hypotension, hypertension, and bradycardia).In Italy, the use of 
dexmedetomidine in children outside the operating room was approved in 2016.Nevertheless, studies on its 
use for diagnostic and therapeutic procedures in special pediatric population are so far limited,and up to date 
guidelines and protocols in children are still missing.  
The aim of the present is to evaluate the effectiveness and safety of intravenous dexmedetomidine in 
pediatric patients with behavioural disorders undergoing EEG recording. 
Methods 
Setting 
This single-center prospective study will be carried out at the Department of Woman and Child's Health of 
Padova, a tertiary pediatric teaching hospital in Northern. 
Study population  


We will include all consecutive patients referred to our Pediatric Neurology and Neurophysiology Unit to 
perform a sleep-EEG after failing the usual local protocol based on parents' education, melatonin 
administration, and/or sleep deprivation according to the age of patient.  
Inclusion criteria:  
- 
age between 1 month and 15 years 
- 
acute or chronic behavioural disorder 
- 
American Society of Anesthesiologists (ASA) status of 1 or 2 
- 
written informed consent by a parent or legal guardian.  
Exclusion criteria:  
- 
patients with failure to gain peripheral vein access, previous hypersensitivity re- action to 
dexmedetomidine 
- 
contraindications to administration of dexmedetomidine (cardiac failure, cardiac arrhythmias, long 
QT syndrome, bradycardia, hypotension, use of betablockers or digoxin, uncontrolled arterial 
hypertension, recent stroke or intracranial bleeding, Moya-Moya syndrome) 
- 
use of sedative drugs in the previous 8 hours 
- 
presence of vomit or gastroesophageal reflux, and craniofacial abnormalities 
Intervention  
Each patient will be evaluated by a pediatrician involved in the study to verify inclusion and exclusion 
criteria and to assess clinical condition of the child, including fasting (6 hours for meals, 4 hours for breast 
milk, 2 hours for liquids). Sedation will be administered by a Pediatric Intensivist in an emergency equipped 
room. Equipment will be comprehensive of wall oxygen supply and devices for basic and advanced airway 
management, including bag masks, oropharyngeal airway, laryngeal mask airway and complete equipment 
for intubation, defibrillator, suction devices, and nasogastric tubes. Before each procedure, the pediatric 
intensivist will check each device to control its functioning. The pediatric intensivist will stay with the 
patient throughout the procedure, monitoring the parameters in order to anticipate and promptly treat any 
possible problem or complication. In the EEG room, an oxygen tank and emergency medical bag with all the 
equipment previously described was always present. Patients will finally get back to the ward or emergency 
department's room until complete recovery. Oxygen saturation, respiratory rate, heart rate, blood pressure, 
end tidal CO2 (EtCO2), and Pediatric Sedation State Scale (PSSS) score will be recorded continuously, 
every 5 minutes, from the beginning of the sedation until complete recovery, defined by NICE guidelinesas a 
complete return to presedation state.  


An intravenous bolus of dexmedetomidine (2 mcg/kg over 10 minutes) will be administered, followed by 
continuous infusion (1-2 mcg/kg/hour), interrupted at the end of the procedure. The bolus may be repeated 
up to 3 times to reach the optimal target level of sedation, before starting the continuous infusion. The target 
level of sedation is defined as a score of 2 assessed by using the PSSS, corresponding to a child in a quiet 
state (asleep or awake), not moving during the procedure. If PSSS of 2 will not be achieved, despite the 
dexmedetomidine boluses and infusion, an additional sedative drug of the physician's choice will be 
administered, considering as a failed procedure for the study.  
We will register time to falling asleep (onset time), to first awakening and to complete recovery after the 
procedure (offset time).  
Duration 
The study will last 18 months. 
Outcome measures 
Primary outcome: The primary outcome is to evaluate efficacy of dexmedetomidine, consisting in number of 
patients that reach a score of 2 five minutes after the infusion of dexmedetomidine assessed by the PASS 
(Pediatric Sedation State Scale)  
Secondary outcome: The secondary outcome is to evaluate the safety of dexmedetomidine, consisting in 
adverse events immediately after dexmedetomidine infusion, according to the world SIVA classification re- 
cording tool.Hypotension and hypertension were defined as a decreasing or increasing of blood pressure of 
more than 25% as compared to baseline values measured before the administration of the drug or to age-
specific normal valuesif the patients were particularly agitated before the procedure. The same definitions 
were used for bradycardia and tachycardia using heart rate values.  
Statistics 
Data will be registered in an Excel spreadsheet and analyzed with SAS 9.4 (SAS Institute Inc) for Windows. 
Quantitative variables will be reported as mean, standard deviation, median, interquartile ranges, minimum, 
and maximum values. Categorical variables will be expressed as number and percentage of subject in each 
category. Comparisons between groups will be conducted with Wilcoxon-Mann-Whitney test for 
quantitative variables, with Fisher's exact test for categorical variables. Spearman's rank correlation 
coefficient will be used to assess the correlation between quantitative variables. A P-value < .05 will be 
considered statistically significant.  
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