drugset / Trial / NCT04270708

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

NCT04270708 ↗

Phase 4 Unknown 200 enrolled Rabin Medical Center
RandomizedParallel-groupDouble-blindSupportive care

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.

Timeline

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

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 3 ug/kg Intranasal
Comparator Triclofos Small molecule 50 mg/kg Oral

Indications