Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED - Trial NCT06364540

Timeline & Enrollment

Primary Outcome

Reduction of pain scores on the numeric rating pain scale (NRS)

Summary

In situations where intravenous access is not readily available or is unobtainable and the
 intranasal route is not feasible, another non-invasive route of ketamine administration, such
 as inhalation via breath-actuated Nebulizer (BAN), is becoming a viable alternative. The BAN
 allows the controlled, patient-initiated delivery of analgesics in a measured and titratable
 fashion. (18) Ketamine has been studied as a nebulized drug in a lot of different settings
 and for a lot of different reasons, such as to treat acute pain after surgery (like a sore
 throat after being intubated), as a pre-medication for general anesthesia, to treat cancer
 pain, and as a therapy for asthmaticus.
 
 Our research team has published two case series of 10 adult patients who were given nebulized
 ketamine (via BAN) for a variety of acute traumatic and non-traumatic painful conditions. The
 patients showed a 60% decrease in pain and a small number of side effects. Furthermore, our
 group published a randomized, double-blind trial of 120 adult patients evaluating the
 analgesic efficacy and safety of nebulized ketamine at three different dosing regimens for
 acute pain in the ED (0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg), showing similar analgesic efficacy
 between the three different dosing regimens for short-term (up to 120 minutes) pain relief.
 Lastly, we recently completed a randomized, double-blind, double-dummy clinical trial
 comparing the analgesic efficacy and safety of nebulized ketamine and intravenous ketamine in
 managing acute pain in adult ED patients, with data currently being analyzed.
 
 Nebulized fentanyl given in the ED to adults with acute traumatic and non-traumatic pain
 syndromes at a dose range of 1.5-4 mcg/kg showed the same or even better pain-relieving
 effects than IV fentanyl and IV morphine alone.
 
 Our objective is to compare the analgesic efficacy and rates of side effects of a 0.75 mg/kg
 dose of ketamine administered via breath-actuated nebulizer (BAN) to a dose of 3 mcg/kg of
 fentanyl administered via breath-actuated nebulizer (BAN) in adult patients presenting to the
 ED with acute painful conditions.

ICD-10 Classifications