Intranasal Dexmedetomidine vs Oral Triclofos Sodium for EEG in Children With Autism

NCT04270708 | Unknown Phase 4

• 1 other identifier: 0090-20-RMC
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Children with Autistic Spectrum Disorder (ASD) often undergo an Electroencephalography (EEG) as part of routine work up. These children present a challenge to successful EEG execution, due to a lack of co-operation, and thus, are often in need of sedation. Historically we have used orally administered, Triclofos Sodium (TFS) - pharmacologically and physiologically similar to chloral hydrate, for sedation in this age group. However success using this drug is limited to approximately 75% in those aged 5 years and above, and possibly lower in this age group when associated with a diagnosis of ASD. The medication is often poorly tolerated by the oral route, and involves patient agitation, spiting (with incomplete drug ingestion), and immediate vomiting upon administration. Recently we have introduced Intra-nasal Dexmedetomidine (IN DEX), with an initial impression of much improved drug acceptance and possibly improved efficacy over TFS. We designed this pilot study, with the aim of comparing efficacy, tolerance of drug administration and adverse events between TFS and IN DEX, with the goal of generating initial results as well as feasibility of recruitment for a larger trial.

Conditions

Autistic Disorder

Keywords

Sedation

Outcome Measures

Primary Outcomes (2)

• Maximal Sedation Depth

  Maximal Sedation Depth by the University of Michigan Sedation Scale (UMSS)

  Within 90 minutes

• Technician satisfaction from sedation

  Technician Ability to complete exam in satisfactory fashion - VAS score

  Within 90 minutes

Secondary Outcomes (7)

• Neurologist satisfaction from EEG motion artifact

  Within 7 days

• Compliance with IN vs Oral Delivery

  Immediate upon administration

• Resistance to drug administration (1-10 scale)

  Immediate upon administration

• Achieving sedation following single dose

  Within 45 minutes

• Achieving sedation following rescue dose

  within 90 minutes

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Intranasal Dexmedetomidine 3mcg/kg

Drug: Dexmedetomidine

Triclofos

ACTIVE COMPARATOR

Oral Triclofos Sodium 50mg/kg

Drug: Triclofos 100 MG/ML

Interventions

Dexmedetomidine DRUG

Patients with Autism will be treated with intranasal Dexmedetomidine as a sedative for EEG

Dexmedetomidine

Triclofos 100 MG/ML DRUG

Patients with Autism will be treated with oral Triclofos as a sedative for EEG

Triclofos

Eligibility Criteria

• Age: 3 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 4-18 yrs referred for an EEG under sedation..
• A Neurologist derived diagnosis of Autistic Spectrum Disorder (ASD).
• ASA 1 or 2

You may not qualify if:

• Allergy to study drug
• Congenital heart disease, bradycardia \< 60 or know arrhythmia/AV block.
• Vasoactive drugs or treatment for arterial HTN.
• Known Renal dysfunction Creatinine Clearance \< 30% or known Liver dysfunction (Elevated LFT's).
• Concurrent Treatment with drugs know to interact with Dexmedetomidine:
• Atipical Antipsychotics / Phenothiazines
• Tricyclic anti-depressents
• Lacosamide treatment - Antiepileptic.
• PDE V inhibitors (Viagra)
• Beta-blockers
• Phenothiazines
• First generation Anti-histamines
• Significant rhinorrhea.

Sponsors & Collaborators

• Rabin Medical Center: lead

Related Publications (18)

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• Grissinger M. Chloral Hydrate: Is It Still Being Used? Are There Safer Alternatives? P T. 2019 Aug;44(8):444-459.

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  PMID: 31292919 RESULT

• Mason KP, Lubisch N, Robinson F, Roskos R, Epstein MA. Intramuscular dexmedetomidine: an effective route of sedation preserves background activity for pediatric electroencephalograms. J Pediatr. 2012 Nov;161(5):927-32. doi: 10.1016/j.jpeds.2012.05.011. Epub 2012 Jun 15.

  PMID: 22704249 RESULT

• Liu H, Sun M, Zhang J, Tian Q, Yu Q, Liu Y, Yang F, Li S, Tu S. Determination of the 90% effective dose of intranasal dexmedetomidine for sedation during electroencephalography in children. Acta Anaesthesiol Scand. 2019 Aug;63(7):847-852. doi: 10.1111/aas.13372. Epub 2019 Apr 14.

  PMID: 30982953 RESULT

• Baier NM, Mendez SS, Kimm D, Velazquez AE, Schroeder AR. Intranasal dexmedetomidine: an effective sedative agent for electroencephalogram and auditory brain response testing. Paediatr Anaesth. 2016 Mar;26(3):280-5. doi: 10.1111/pan.12851.

  PMID: 26814037 RESULT

• Gumus H, Bayram AK, Poyrazoglu HG, Canpolat DG, Per H, Canpolat M, Yildiz K, Kumandas S. Comparison of Effects of Different Dexmedetomidine and Chloral Hydrate Doses Used in Sedation on Electroencephalography in Pediatric Patients. J Child Neurol. 2015 Jul;30(8):983-8. doi: 10.1177/0883073814549582. Epub 2014 Sep 22.

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  PMID: 24823763 RESULT

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• Xie Z, Shen W, Lin J, Xiao L, Liao M, Gan X. Sedation effects of intranasal dexmedetomidine delivered as sprays versus drops on pediatric response to venous cannulation. Am J Emerg Med. 2017 Aug;35(8):1126-1130. doi: 10.1016/j.ajem.2017.03.021. Epub 2017 Mar 18.

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MeSH Terms

Conditions

Autistic Disorder

Interventions

Dexmedetomidine; triclofos

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pediatric Sedation Services, Schneider Children's Medical Center of Israel

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: March 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 17, 2020

Record last verified: 2020-02