Comparison of Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED: A Prospective, Randomized, Double-Blind Clinical Trial.
Antonios Likourezos
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.
Description
This is a prospective, randomized, double-blind trial comparing the analgesic efficacy and safety of nebulized ketamine administered at 0.75 mg/kg via BAN to nebulized fentanyl administered at 3 mcg/kg via BAN to adult patients presenting to the ED of Maimonides Medical Center with acute painful conditions of moderate to severe intensity. The dosing of nebulized fentanyl at three mcg/kg is based on two randomized, dose-finding clinical trials of acute pain where a one mcg/kg dose was compared to a 3 mcg/kg dose with resultant analgesic superiority of the 3 mcg/kg dose (26, 27). The dose of neb…
Eligibility
- Age range
- 18–120 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * age 18+ years * acute painful condition * pain score of 5 or more on a standard 11 point numeric rating scale (NRD) * patient needs to be awake, alert, and oriented as to person, place, and time * demonstrated understanding of the informed consent process and content * patient needs to demonstrate the ability to verbalize the nature of any adverse effects (AE) * patient needs to experience as well as express their pain severity by using the NRS Exclusion Criteria: * patient with a painful condition warranting emergent/urgent intervention in the ED * patients with alter…
Interventions
- DrugKetamine
Nebulized ketamine administered at 0.75 mg/kg via BAN
- DrugFentanyl
Nebulized fentanyl administered at 3 mcg/kg via BAN
Location
- Maimonides Medical CenterBrooklyn, New York