About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
patient with a painful condition warranting emergent/urgent intervention in the ED
patients with altered mental status
allergy to ketamine or fentanyl
pregnant or breastfeeding
Trial design
Parallel
Treatments tested in this trial
Ketamine
DrugNebulized ketamine administered at 0.75 mg/kg via BAN
Fentanyl
DrugNebulized fentanyl administered at 3 mcg/kg via BAN
Treatment groups
Trial outcomes
Primary outcomes
Reduction of pain scores on the numeric rating pain scale (NRS)
comparative reduction of pain scores on the numeric rating pain scale (NRS) between recipients of KetaBAN and FentaBAN
Secondary outcomes
Need for Rescue Analgesia
Assess whether any patients needed rescue analgesia at any time up to 120 minutes
Severity of Adverse Events
With respect to the unique adverse effects of SDK, we will use the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). . Subjects will rate the severity of each side effect on a five-point scale, with "0" denoting the absence of any negative effects and "4" denoting a side effect that is extremely bothersome. The SERSDA Scale includes fatigue, dizziness, nausea, headaches, feelings of unreality, changes in hearing, mood changes, general discomfort, and hallucinations.
Evaluation of Severity of agitation and/or sedation
The Richmond Agitation Sedation Scale (RASS)evaluates the severity of agitation and/or sedation in accordance with the nine-point scale, with scores ranging from "-4" (deeply sedated) to "0" (alert and calm) to "+4" (combative).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Antonios Likourezos
Lead sponsor
Maimonides Medical Center
Sponsor institution