Behavior Disorders, Procedural Sedation
Conditions
Keywords
dexmedetomidine, sedation
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.
Interventions
DRUGdexmedetomidine
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
Sponsors
Azienda Ospedaliera di Padova
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Drug administration by a loading dose followed by continuous infusion during a procedure
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* children affected by behavior disorders who underwent EEG procedure with sedation * written informed consent
Exclusion criteria
* ASA \> 2 * hypersensitivity of active substance * therapy with beta blockers or digoxin, arrhythmia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale) | 10 minutes | the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events | during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening) | any adverse event potentially related with DEX-administration |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexmedetomidine 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
dexmedetomidine: To administrater 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 | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Dexmedetomidine | — |
|---|---|---|
| Age, Continuous | 7.3 years STANDARD_DEVIATION 4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 10 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale)
the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine.
Time frame: 10 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexmedetomidine | Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale) | 13 Participants |
Secondary
Number of Patients With Adverse Events
any adverse event potentially related with DEX-administration
Time frame: during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexmedetomidine | Number of Patients With Adverse Events | 10 Participants |