Intranasal Dexmedetomidine vs Oral Triclofos Sodium Sedation for Children With Autism Undergoing Electroencephalograms - A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 主要终点
- Maximal Sedation Depth
研究概览
简要总结
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.
详细描述
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 on the day of the planned examination.
Patients aged 4yrs and above, with a diagnosis of ASD will be allocated and investigated for fulfillment of inclusion and exclusion criteria for study participation. The legal guardians of patients meeting study criteria will be approached for study participation consent. Patients declining consent will be treated with TFS as per current protocol. Patients for whom consent is attained will comprise the study group.
Study group patients will be randomized for treatment and stratified according to age groups: 4-7, 8-12, 12-18. Treatment will consist of 2 alternative pathways:
Oral Trichlofos Sodium (TFS) Pathway:
- Initial Drug dose: Patients will be treated orally with 50mg/kg of TFS to maximum of 2000gr.
- Failure to achieve sedate state 45 minutes after drug administration will enable an additional oral dose of 25mg/kg.
- Patients failing to fall asleep following second drug dose will be regarded as treatment failure.
- Rescue therapy according to physician's choice can be instituted (Dexmed or Neuleptil).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-18 yrs referred for an EEG under sedation..
- •A Neurologist derived diagnosis of Autistic Spectrum Disorder (ASD).
排除标准
- •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.
研究组 & 干预措施
Dexmedetomidine
Intranasal Dexmedetomidine 3mcg/kg
干预措施: Dexmedetomidine (Drug)
Triclofos
Oral Triclofos Sodium 50mg/kg
干预措施: Triclofos 100 MG/ML (Drug)
结局指标
主要结局
Maximal Sedation Depth
时间窗: Within 90 minutes
Maximal Sedation Depth by the University of Michigan Sedation Scale (UMSS)
Technician satisfaction from sedation
时间窗: Within 90 minutes
Technician Ability to complete exam in satisfactory fashion - VAS score
次要结局
- Resistance to drug administration (1-10 scale)(Immediate upon administration)
- Achieving sedation following rescue dose(within 90 minutes)
- Sedation onset, duration and recovery periods(Within 4 hours.)
- Neurologist satisfaction from EEG motion artifact(Within 7 days)
- Compliance with IN vs Oral Delivery(Immediate upon administration)
- Achieving sedation following single dose(Within 45 minutes)
- Adverse Events(Within 4 hours.)
研究者
Eytan Kaplan
Director of Pediatric Sedation Services, Schneider Children's Medical Center of Israel
Rabin Medical Center