Intranasal Dexmedetomidine vs Oral Triclofos Sodium for EEG in Children With Autism
Status:
Not yet recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
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.