Alfentanil versus fentanyl with ketamine for emergency department rapid sequence intubation: The A-FAKT study, a randomised clinical trial.
A comparison of alfentanil with fentanyl on the post-induction haemodynamics of patients undergoing rapid sequence intubation with ketamine and rocuronium in the emergency department: The A-FAKT study, a pilot randomised controlled trial.
South West Sydney Local Health District
60 participants
Aug 12, 2022
Interventional
Conditions
Summary
A small number of patients presenting to emergency departments need intubation, a process to place a tube in their windpipe to protect their airway, and allow breathing support with a ventilator. Drugs are used to ensure that they are unconscious and to relax their muscles to make placement of the tracheal tube possible, but these drugs can cause changes to vital signs such as pulse and blood pressure, which could worsen their condition. Ketamine is often used as a sedative agent for intubation, and an opioid (morphine-like) drug is sometimes used to try and normalise the blood pressure during the procedure. Fentanyl is the most commonly used opioid for this purpose, but another drug called alfentanil is theoretically a better choice. In this clinical trial, we intend to randomise patients to receive equivalent doses of either fentanyl or alfentanil, in a blinded fashion, as part of a drug regimen with ketamine and a muscle relaxant called rocuronium. The study aims to test the null hypothesis that there is no difference in the outcomes measured between fentanyl and alfentanil.
Eligibility
Plain Language Summary
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Interventions
Arm one will receive 2.5 - 15 micrograms per kilogram of alfentanil intravenously in addition to ketamine and rocuronium to facilitate rapid sequence intubation. The bolus of alfentanil will be given immediately prior to the other medications in the regimen (ketamine, followed by rocuronium) without a significant pause between. The volume of intravenous alfentanil administered will be the equivalent that the treating doctor would administer if using open label fentanyl in a concentration of 10 micrograms per millilitre. I.e. if the treating doctor would aim to administer 100 micrograms of open label fentanyl (10 ml in the concentration used in this study), they would administer 10 ml (containing 500 mcg) of alfentanil in this arm. The volume of medication administered will be recorded on the case report form, and also in a separate controlled drugs register, which will be checked by two independent staff members.
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ACTRN12621001764820