FentAnyl or placebo with Ketamine and rocuronium for rapid sequence inTubation in the emergency department, a multicentre randomised controlled trial: the FAKT study
A randomised, double blind, placebo controlled trial evaluating the impact of fentanyl as an adjunct to ketamine and rocuronium on post-induction haemodynamics & 30 day mortality of patients undergoing rapid sequence of intubation in the emergency department.
Ian Ferguson
300 participants
Aug 25, 2018
Interventional
Conditions
Summary
Ketamine is an induction agent to induce general anaesthesia in the emergency department, associated with less frequent episodes of hypotension than other agents such as thiopentone1 or propofol2. However, it is typically associated with increases in blood pressure in stable patients, and can cause hypotension in shocked patients3. In critically ill patients, avoiding hypotension is important, as it’s occurrence is known to be associated with poor outcomes4, particularly in the head injured patient5. However, hypertension is also associated with poorer outcomes, particularly in patients with intracranial bleeds (although cause and effect is not established) 6, and is usually avoided in haemorrhagic shock, due to consensus concern about increasing bleeding7,8. Co-administration of fentanyl during rapid sequence induction has been advocated as leading to less deviation from baseline haemodynamics9. It remains unclear whether in the emergency department and pre-hospital setting, this has any significant impact on mortality, and this exploratory study aims to evaluate whether patients undergoing RSI with ketamine and fentanyl, rather then ketamine and placebo have fewer episodes of adverse haemodynamic effects (systolic blood pressure less to 91 mmHg or greater than 149 mmHg) within the first 10 minutes following induction, and whether there is a subsequent difference in mortality at 3, 7 and 30 days. The study will be powered to detect a difference in the percentage of patients who meet the primary endpoint of low or high blood pressure, and will be used to inform future work regarding difference in mortality benefit. 1. White PF. Comparative evaluation of intravenous agents for rapid sequence induction –thiopental, ketamine and midazolam. Anaethesiology, Oct 1982; 57(4): 279-84 2. Hug CC Jr et al. Haemodynamic effects of propofol: Data from over 25,000 patients. Anaethesia and Analgesia, 1993; 77 (4 suppl):S21-9. 3. Miller M et al. The haemodynamic response following ketamine induction for pre-hospital anaesthesia in shocked and non-shocked patients. Ann Emerg Med, 2016 April; 4. Hefner AC et al. The frequency and significance of post-intubation hypotension during emergency airway management. J Crit Care. 2012 Aug; 27(4):417, e9-13. 5. Manly G, et al. Hypotension, hypoxia and head injury: Frequency, duration and consequences. Archiv Surg. 2001 Oct; 136(10):1118-23. 6. Honner SK et al. Emergency department control of blood pressure in intracerebral haemorrhage. J Emerg Med. 2011; 414(4): 355-61. 7. Bickell WH, Wall MJ Jr, Pepe PE, Martin RR, Ginger VF, Allen MK, Mattox KL. Immediate versus delayed fluid resuscitation for hypotensive patients with penetrating torso injuries. N Engl J Med. 1994 Oct 27;331(17):1105-9. 8. Dutton RP, Mackenzie CF, Scalea TM. Hypotensive resuscitation during active hemorrhage: impact on in-hospital mortality. J Trauma. 2002 Jun;52(6):1141-6. 9. Lyon RM et al. Significant modification of traditional r
Eligibility
Inclusion Criteria3
- Any patient over the age of 18 who:
- Requires rapid sequence intubation, and;
- In whom the proposed induction regime is at least as suitable as any of the alternatives in the opinion of the treating doctor.
Exclusion Criteria1
- Age <18 years, known or suspected allergy to ketamine, fentanyl or rocuronium, requirement for paralysis only induction, or an alternative induction regime required in the opinion of the treating physician.
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Interventions
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 2mcg/kg (standard dose) or 1mcg/kg (reduced dose) as an intravenous bolus. The drugs will be administered 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.
Locations(5)
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ACTRN12616001570471