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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events | any adverse event potentially related with DEX-administration | during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| angela amigoni, MD | azienda Ospedaliera di Padova-Pediatric Intensive Care Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Intensive Care Unit - Department of Woman's and Child's Health - Azienda Ospedaliera di Padova | Padova | PD | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20017865 | Background | Mason KP, O'Mahony E, Zurakowski D, Libenson MH. Effects of dexmedetomidine sedation on the EEG in children. Paediatr Anaesth. 2009 Dec;19(12):1175-83. doi: 10.1111/j.1460-9592.2009.03160.x. | |
| 28557732 | Result | Cravero JP, Askins N, Sriswasdi P, Tsze DS, Zurakowski D, Sinnott S. Validation of the Pediatric Sedation State Scale. Pediatrics. 2017 May;139(5):e20162897. doi: 10.1542/peds.2016-2897. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 10 minutes |
|
90 minutes
Other (not including serious) adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypotension | Cardiac disorders | Systematic Assessment | spontaneously resolved |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Amigoni, MD | University Hospital Padova | 339 8333765 | ++39 | Angela.amigoni@aopd.veneto.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2020 | Nov 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Drug administration by a loading dose followed by continuous infusion during a procedure
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|
| 22536619 | Result | National Clinical Guideline Centre (UK). Sedation in Children and Young People: Sedation for Diagnostic and Therapeutic Procedures in Children and Young People [Internet]. London: Royal College of Physicians (UK); 2010 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK82237/ |
| 27354454 | Result | Cote CJ, Wilson S; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016 Jul;138(1):e20161212. doi: 10.1542/peds.2016-1212. |
| 27516413 | Result | Sulton C, McCracken C, Simon HK, Hebbar K, Reynolds J, Cravero J, Mallory M, Kamat P. Pediatric Procedural Sedation Using Dexmedetomidine: A Report From the Pediatric Sedation Research Consortium. Hosp Pediatr. 2016 Sep;6(9):536-44. doi: 10.1542/hpeds.2015-0280. Epub 2016 Aug 11. |
| 25145661 | Result | Keidan I, Ben-Menachem E, Tzadok M, Ben-Zeev B, Berkenstadt H. Electroencephalography for children with autistic spectrum disorder: a sedation protocol. Paediatr Anaesth. 2015 Feb;25(2):200-5. doi: 10.1111/pan.12510. Epub 2014 Aug 22. |
| 19589455 | Result | Lubisch N, Roskos R, Berkenbosch JW. Dexmedetomidine for procedural sedation in children with autism and other behavior disorders. Pediatr Neurol. 2009 Aug;41(2):88-94. doi: 10.1016/j.pediatrneurol.2009.02.006. |
| 16238552 | Result | Zub D, Berkenbosch JW, Tobias JD. Preliminary experience with oral dexmedetomidine for procedural and anesthetic premedication. Paediatr Anaesth. 2005 Nov;15(11):932-8. doi: 10.1111/j.1460-9592.2005.01623.x. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Patients With Adverse Events | any adverse event potentially related with DEX-administration | Posted | Count of Participants | Participants | during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening) |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 10 |
| 19 |
| bradycardia | Cardiac disorders | Systematic Assessment | spontaneously resolved |
|
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