Status:
UNKNOWN
Intranasal Dexmedetomidine vs Oral Triclofos Sodium for EEG in Children With Autism
Lead Sponsor:
Rabin Medical Center
Conditions:
Autistic Disorder
Eligibility:
All Genders
3-19 years
Phase:
PHASE4
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 o...
Detailed Description
Study participants will be allocated, amongst patients invited for routine EEG monitoring in the hospitals EEG facility. All patients will be fasted on arrival, with a recommendation to awaken early o...
Eligibility Criteria
Inclusion
- Children aged 4-18 yrs referred for an EEG under sedation..
- A Neurologist derived diagnosis of Autistic Spectrum Disorder (ASD).
- ASA 1 or 2
Exclusion
- Allergy to study drug
- Congenital heart disease, bradycardia \< 60 or know arrhythmia/AV block.
- Vasoactive drugs or treatment for arterial HTN.
- Known Renal dysfunction Creatinine Clearance \< 30% or known Liver dysfunction (Elevated LFT's).
- Concurrent Treatment with drugs know to interact with Dexmedetomidine:
- Atipical Antipsychotics / Phenothiazines
- Tricyclic anti-depressents
- Lacosamide treatment - Antiepileptic.
- PDE V inhibitors (Viagra)
- Beta-blockers
- Phenothiazines
- First generation Anti-histamines
- Significant rhinorrhea.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04270708
Start Date
March 1 2020
End Date
August 1 2022
Last Update
February 17 2020
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