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

ConditionPain, Acute
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-120
SponsorAntonios Likourezos

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ketamine

    Drug

    Nebulized ketamine administered at 0.75 mg/kg via BAN

  • Fentanyl

    Drug

    Nebulized fentanyl administered at 3 mcg/kg via BAN

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Nebulized KetaBANActive comparator 1 intervention
Group B: Nebulized FentaBANActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
30 minutes

Secondary outcomes

1

Need for Rescue Analgesia

Assess whether any patients needed rescue analgesia at any time up to 120 minutes

Time frame
30-120 minutes
2

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.

Time frame
30-120 minutes
3

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).

Time frame
30-120 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Antonios Likourezos

Lead sponsor

Maimonides Medical Center

Sponsor institution