FentAnyl or placebo with Ketamine and rocuronium for rapid sequence inTubation in the emergency department, a multicentre randomised controlled trial: the FAKT study

INTERVENTION: Patients requiring rapid sequence intubation in the emergency department using ketamine and rocuronium in the opinion of their treating doctor will be randomised to one of two arms in a 1:1 ratio. In addition to the trial medication (described below), each patient will receive either ketamine 1mg/kg + rocuronium 1.5mg/kg (reduced dosing group), or ketamine 2mg/kg + rocuronium 1.5mg/kg (standard dose). The medications will be administered as an intravenous bolus. As the requirement for reduced dosing is multifactorial, and is not readily distilled into an algorithm, the decision as to whether to use standard or reduced dosing will be at the discretion of the treating doctor (who will be at least a senior registrar) using clinical gestalt. The treatment arm will receive the medication detailed above, preceded by fentanyl 2mg/kg (standard dose) or 1mg/kg (reduced dose) as an intravenous bolus. The drugs will be adminstered in the order of fentanyl (or placebo), followed by ketamine, followed by rocuronium, in a rapid sequence. Following the administration of the medications, intubation will proceed in a standardised fashion. CONDITION: Rapid sequence intubation PRIMARY OUTCOME: The percentage of patients with a systolic blood pressure falling outside of the range of 100‐150mmHg. SECONDARY OUTCOME: All cause mortality Cardiac arrest (loss of palpable pulse and ETC02<10, associated with the use of cardiac compressions or commencement of procedures to reverse traumatic cardiac arrest). Cormack‐Lehane laryngoscopic view. Number of ventilator‐free days Percentage of patients in whom the use of a supraglottic airway devices is necessary. Percentage of patients intubated on the first pass (i.e. following a single laryngoscope insertion by a single operator). Percentage of patients undergoing cricothyroidotomy. Secondary end‐points of hypoxia (Sp02 less than or equal to 93%), as measured by continuous pulse oximetry. Tachycardia (HR greater than or equal to 120), as measured using continuous three lead cardiac monitoring. ; ; INCLUSION CRITERIA: Any patient over the age of 18 who: 1) Requires rapid sequence intubation, and; 2) In whom the proposed induction regime is at least as suitable as any of the alternatives in the opinion of the treating doctor.