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临床试验/ACTRN12616000399493
ACTRN12616000399493尚未招募2 期

Ketamine Intranasal Delivery in the Emergency Room: A multicentre randomised controlled trial of Intranasal(IN) versus Intravenous(IV)/Intramuscular(IV) ketamine for paediatric sedation in the Emergency Department. Is a totally needle-free approach feasible?

The Townsville Hospital and Health Service0 个研究点目标入组 652 人开始时间: 2016年3月29日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
652

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
12 Months 至 11 Years(—)
性别
All

入选标准

  • 1. Child of aged between greater than or equal to 12 months and less than or equal to 11 years
  • 2. Weight between greater than or equal to 10kg and less than or equal to 40kg; corresponding to 100-400mg IN ketamine
  • 3. Considered by appropriately qualified senior treating clinician (FACEM or SMO) to have an indication for emergency department sedation

排除标准

  • 1. IV cannula already in situ at time of consideration for recruitment; or required for non-sedation indications prior to initiation of the sedation
  • 2. Any previous adverse reaction or allergy to ketamine or other components of Ketalar (registered trade name)
  • 3. Past history of significant cardiac disease, especially pulmonary hypertension
  • 4.American Society of Anaesthesiology Classification > 1
  • 5. Predicted difficult bag-mask ventilation or laryngoscopy
  • 6. Critical illness
  • 7. Severe trauma
  • 8. Procedure better managed in operating theatre
  • 9. Communicating hydrocephalus or other pre-existing condition predisposing to raised intracranial pressure (head injury is not an exclusion criteria unless meeting definition of major trauma)
  • 10. Disease of the nose, significant coryza or nasal discharge, nasal obstruction or other condition preventing effective administration by the IN route

研究者

发起方
The Townsville Hospital and Health Service

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