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Ketamine Clinical Trials


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?


To see complete record on anzctr.org.au, please visit this link

Id: ACTRN12616000399493p

Organisation Name: The Townsville Hospital and Health Service

Overal Status: Not yet recruiting

Start Date: 01/08/2016

Brief Summary: Sedation of children in the Emergency Department (ED) for either urgent therapeutic procedures that may be painful or which require a still and cooperative child (such as wound closure, abscess drainage, foreign body removal, lumbar puncture or fracture reduction) or to obtain critical diagnostic information (for example via medical imaging) is an important aspect of emergency medical practice for which a considerable and evolving body of evidence has developed over several decades. Sedation and analgesia for painful procedures is certainly considered a standard of care that should be offered to all children undergoing painful procedures where possible. While there are some published guidelines there is considerable variation in practice both locally and internationally in terms of choice of sedative agent and conduct of the procedure of sedation. Most of the literature relates to parenteral routes of administration of sedative drugs, typically intravenous (IV) or intramuscular (IM) routes, due to the ability to titrate the dose and the reliability of drug effects when administered via these routes.

Study aims
1. Investigate the feasibility of a novel needle-free approach to paediatric sedation in the emergency department
2. Investigate the scientific merit of IN ketamine sedation of children in the emergency department
3. Investigate the practical merit of IN ketamine sedation of children in the emergency department
4. Improve emergency paediatric sedation practices consistent with humane processes of paediatric emergency care
5. Establish a greater evidence base for the intranasal route of sedative drug administration in the emergency department
Study hypotheses
1. That IN ketamine sedation will not require significant rates of IV cannulation to safely complete the procedure where an IV cannula is not already considered essential for a patient’s ongoing care
2. That IN ketamine (10mg/kg) will provide non-inferior sedation compared with IV ketamine (1.0-2.0mg/kg) and IM ketamine (4-5mg/kg)
3. That IN ketamine would be associated with higher parental/caregiver satisfaction with the overall procedure and general care in the emergency department
4. That IN ketamine would be associated with greater physician satisfaction with the overall performance of the sedation and the process required to ready the patient for sedation
5. That IN ketamine sedation will lead to earlier readiness for performance of the procedure or diagnostic intervention and hence earlier procedural completion
6. That IN ketamine sedation will not be associated with an overall increase in ED length of stay
7. That IN ketamine sedation will not be associated with an increased rate of emesis, unpleasant psychomimetic effects or other adverse events

Countries:
  • Australia


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