The safety and efficacy of intranasal ketamine delivery for sedation of children in the emergency department. Is a needle-free approach to the care of children in the emergency department, practical and attainable?
- Conditions
- Sedation procedures in childrenAnaesthesiology - Other anaesthesiology
- Registration Number
- ACTRN12616000399493
- Lead Sponsor
- The Townsville Hospital and Health Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 652
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method