The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders

NCT03799783 | Completed Phase 2 Results

• 1 other identifier: 4422/AO/18
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Sedation; Behavior Disorders

Keywords

dexmedetomidine; sedation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Patients With Adverse Events

  during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening)

Study Arms (1)

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

Drug: dexmedetomidine

Interventions

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

Also known as: dexdor

Dexmedetomidine

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children affected by behavior disorders who underwent EEG procedure with sedation
• written informed consent

You may not qualify if:

• ASA \> 2
• hypersensitivity of active substance
• therapy with beta blockers or digoxin, arrhythmia

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead

Study Sites (1)

Pediatric Intensive Care Unit - Department of Woman's and Child's Health - Azienda Ospedaliera di Padova

Padua, PD, Italy

Location

Related Publications (8)

• 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.

  PMID: 20017865 BACKGROUND

• 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.

  PMID: 28557732 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/

  PMID: 22536619 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.

  PMID: 27354454 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.

  PMID: 27516413 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.

  PMID: 25145661 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.

  PMID: 19589455 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.

  PMID: 16238552 RESULT

MeSH Terms

Conditions

Mental Disorders

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Angela Amigoni, MD
• Organization: University Hospital Padova

Angela.amigoni@aopd.veneto.it

339 8333765

Study Officials

• angela amigoni, MD

  azienda Ospedaliera di Padova-Pediatric Intensive Care Unit

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Drug administration by a loading dose followed by continuous infusion during a procedure

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 10, 2019
• Study Start: March 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: September 28, 2019
• Last Updated: February 2, 2021
• Results First Posted: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)