Overview

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

Status:
Not yet recruiting
Trial end date:
2022-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rabin Medical Center
Treatments:
Dexmedetomidine
Criteria
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.