FentAnyl or placebo with KeTamine for emergency department rapid sequence intubation: The FAKT study protocol

Abstract

Background Some critically ill patients require rapid sequence intubation in the emergency department, and ketamine is one sedative agent employed, due to its relative haemodynamic stability. Tachycardia and hypertension are frequent side effects, and in less stable patients, shock can be unmasked or exacerbated. The use of fentanyl as a co‐induction agent may lead to a smoother haemodynamic profile post‐induction, which may lead to reduced mortality in this critically ill cohort. This randomised controlled trial aims to compare the effect of administering fentanyl vs placebo in a standardised induction regimen with ketamine and rocuronium on (a) the percentage of patients in each group with a systolic blood pressure outside the range of 100‐150 mm Hg within 10 minutes of induction, (b) the laryngoscopic view, and (c) 30‐day mortality. Methods/design Three hundred patients requiring rapid sequence intubation in participating emergency departments will be randomised to receive either fentanyl or placebo (0.9% saline) in addition to ketamine and rocuronium according to a standardised, weight‐based induction regimen. The primary outcome measure is the percentage of patients in each group with a systolic blood pressure outside the range of 100‐150 mm Hg within 10 minutes of induction. Secondary outcome measures include the laryngoscopic view, percentage of first pass success, 30‐day mortality and number of ventilator‐free days at 30 days. Discussion The effect of adding fentanyl to an induction regimen of ketamine and rocuronium will be evaluated, both in terms of post‐intubation physiology, the effect on intubating conditions, and 30‐day mortality.

Fentanyl versus placebo with ketamine and rocuronium for patients undergoing rapid sequence intubation in the emergency department: The FAKT study—A randomized clinical trial

“…The protocol was approved by the South West Sydney Local Health District Human Research and Ethics Committee (HREC/17/LPOOL/450) with a waiver of informed consent. The protocol and analysis plan were published prior to completion of recruitment 6 . The trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12616001570471).…”

“…The protocol and analysis plan were published prior to completion of recruitment. 6 The trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12616001570471).…”

Haemodynamic effects of a prehospital emergency anaesthesia protocol consisting of fentanyl, ketamine and rocuronium in patients with trauma: a retrospective analysis of data from a Helicopter Emergency Medical Service

“…Based on these findings, it might be worth to reconsider the dose and timing of fentanyl administration during prehospital trauma RSI. The results of the FAKT trial, 21 a randomised double-blind placebo-controlled trial evaluating the impact of fentanyl as an adjunct to ketamine and rocuronium on postintubation haemodynamics, may hopefully provide more guidance on the optimal dose of fentanyl for prehospital RSI in the near future.…”

Airway Management for the Critically Ill Patient in the Emergency Department

“…These properties make fentanyl an ideal medication for analgesia during induction. 10 The dose most commonly used is 1-3 mcg/kg given over 60 seconds, its onset is roughly 30 seconds with a half-life of 2-4 hours. 11 A common concern when administering fentanyl is rigid or wooden chest syndrome.…”