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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04270708
Recruitment Status : Not yet recruiting
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Information provided by (Responsible Party):
Eytan Kaplan, Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Autistic Disorder Drug: Dexmedetomidine Drug: Triclofos 100 MG/ML Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Intranasal Dexmedetomidine vs Oral Triclofos Sodium Sedation for Children With Autism Undergoing Electroencephalograms - A Randomized Controlled Trial.
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dexmedetomidine
Intranasal Dexmedetomidine 3mcg/kg
Drug: Dexmedetomidine
Patients with Autism will be treated with intranasal Dexmedetomidine as a sedative for EEG

Active Comparator: Triclofos
Oral Triclofos Sodium 50mg/kg
Drug: Triclofos 100 MG/ML
Patients with Autism will be treated with oral Triclofos as a sedative for EEG

Primary Outcome Measures :
  1. Maximal Sedation Depth [ Time Frame: Within 90 minutes ]
    Maximal Sedation Depth by the University of Michigan Sedation Scale (UMSS)

  2. Technician satisfaction from sedation [ Time Frame: Within 90 minutes ]
    Technician Ability to complete exam in satisfactory fashion - VAS score

Secondary Outcome Measures :
  1. Neurologist satisfaction from EEG motion artifact [ Time Frame: Within 7 days ]
    Neurologist satisfaction from EEG motion artifact - VAS score

  2. Compliance with IN vs Oral Delivery [ Time Frame: Immediate upon administration ]
    Compliance with IN vs Oral Delivery - Successful drug administration Y/N?

  3. Resistance to drug administration (1-10 scale) [ Time Frame: Immediate upon administration ]
    Resistance to drug administration (1-10 scale): Crying / spitting or Complete or Partial Rejection for TFS/IN DEX

  4. Achieving sedation following single dose [ Time Frame: Within 45 minutes ]
    Achieving sedation following single dose of Dexmed vs TFS

  5. Achieving sedation following rescue dose [ Time Frame: within 90 minutes ]
    Achieving sedation following additional rescue dose of Dexmed vs TFS

  6. Sedation onset, duration and recovery periods [ Time Frame: Within 4 hours. ]
    Sedation onset, duration and recovery periods

  7. Adverse Events [ Time Frame: Within 4 hours. ]
    Sedation associated adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. Allergy to study drug
  2. Congenital heart disease, bradycardia < 60 or know arrhythmia/AV block.
  3. Vasoactive drugs or treatment for arterial HTN.
  4. Known Renal dysfunction Creatinine Clearance < 30% or known Liver dysfunction (Elevated LFT's).
  5. Concurrent Treatment with drugs know to interact with Dexmedetomidine:

    1. Atipical Antipsychotics / Phenothiazines
    2. Tricyclic anti-depressents
    3. Lacosamide treatment - Antiepileptic.
    4. PDE V inhibitors (Viagra)
    5. Beta-blockers
    6. Phenothiazines
    7. First generation Anti-histamines
  6. Significant rhinorrhea.

Publications of Results:

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Responsible Party: Eytan Kaplan, Director of Pediatric Sedation Services, Schneider Children's Medical Center of Israel, Rabin Medical Center Identifier: NCT04270708    
Other Study ID Numbers: 0090-20-RMC
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eytan Kaplan, Rabin Medical Center:
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action