Ketamine molecule:

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Ketamine Clinical Trials

Ketamine in Acute Behavioural Disturbance

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Id: ACTRN12616001491459

Organisation Name: Vinay Gangathimmaiah

Overal Status: Not yet recruiting

Start Date: 28/10/2016

Brief Summary: Acute behavioural disturbance(ABD), also known as Excited Delirium Syndrome(ExDS), is a medical emergency with reported mortality of 8-10%.. The management of ABD usually necessitates a judicious combination of de-escalation techniques, physical restraints and sedation. Sedation of patients with ABD is usually accomplished with benzodiazepines and antipsychotics, either alone or in combination. The use of these two drug classes can be limited by several factors, primarily respiratory depression with benzodiazepines and a delayed onset of action of up to 20min with antipsychotics. In recent years, several small studies have explored the suitability of ketamine as an alternative agent for sedating patients with ABD in the prehospital, retrieval and emergency settings. Favourable pharmacological properties including rapid onset of action of 2-5min, protection of airway reflexes and maintenance of respiratory drive make ketamine a promising sedative agent in the management of ABD. Nevertheless insufficient data about effectiveness and safety of ketamine in the setting of ABD have prevented it from gaining widespread acceptance for this indication. Firstly, the effectiveness of ketamine sedation in ABD, as measured by sedation failure rates, has varied between no failures in one retrospective study and 10% in a recent prospective study. Furthermore, the reported incidence of endotracheal intubations with ketamine has also varied widely between studies, from no intubations to 39% . Interestingly, a large study looking at the incidence of intubations before and after introduction of a ketamine sedation protocol for ABD found a decrease in incidence from 3.5% to 2.3% while a smaller study using a combination of sedatives including ketamine also reported an intubation rate of 3%. Finally, there is a lack of clarity about the minimum effective ketamine dose needed to achieve safe sedation of behaviorally disturbed patients with reported dose ranges of 0.5-1mg/kg as the initial intravenous dose followed by 1 - 5.56mg/kg/h intravenous infusion and 2.25- 9.42mg/kg as the total intramuscular dose.

Along with benzodiazepines and antipsychotics, ketamine has been a part of the Standard Operating Procedure(SOP) for management of ABD at Lifeflight Retrieval Medicine( previously known as Careflight Retrieval Medicine, Queensland),Australia for over 3 years and Royal Flying Doctor Service(RFDS), Queensland, Australia for over 9 years. We want to examine the experience at these organizations to address our research question of whether ketamine is a safe and effective alternative agent for sedation of patients with acute behavioural disturbance in the aeromedical retrieval setting. Our study hypothesis is that in our aeromedical retrieval setting ketamine reduces the incidence of intubations in patients needing sedation for acute behavioural disturbance compared to the reported incidence of intubations in existing literature.

  • Australia

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