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

NCT04270708 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-02-17

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine

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

DRUG

Triclofos 100 MG/ML

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

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-03-01
Completion
2022-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04270708 on ClinicalTrials.gov