Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06364540 |
Other study ID # |
2023-08-14 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
May 1, 2024 |
Est. completion date |
December 31, 2026 |
Study information
Verified date |
April 2024 |
Source |
Maimonides Medical Center |
Contact |
Antonios Likourezos, MA, MPH |
Phone |
718-283-6896 |
Email |
alikourezos[@]maimo.org |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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 nebulized ketamine is based on the
results of our own randomized clinical trial, which showed that 0.75 mg/kg of nebulized
ketamine was as effective at relieving short-term pain in the ED as 1 mg/kg and 1.5 mg/kg.
Upon meeting the eligibility criteria, patients will be randomized into two study groups:
Nebulized KetaBAN (Ketamine via BAN) and Nebulized FentaBAN (Fentanyl via BAN).
The on-duty ED pharmacist will prepare either a breath-actuated nebulizer (BAN) with 0.75
mg/kg of ketamine or a BAN with 3 mcg/kg of fentanyl, depending on the randomization list,
which will be made in SPSS (version 24; IBM Corp., Armonk, NY) with a block randomization of
every 10 participants. The medication will be delivered to the treating nurse in a blinded
fashion. The nebulization of study drugs via BAN will have a minimum time of 5 minutes and a
maximum time of 15 minutes. If a patient requires further analgesia, a second dose of either
Ketaban or Fentaban will be offered, or intravenous (IV) fentanyl at 0.75 mcg/kg will be
administered as a rescue analgesia.
In addition, study investigators will measure the residual volume of ketamine and fentanyl
remaining in the breath-actuated nebulizer after each treatment and document the results on a
waste sheet designed by the pharmacy staff. The pharmacist will receive this sheet and use it
to determine the actual dose that each study participant received based on their initial
randomization group. According to the departmental policy on the waste of controlled
substances, a treating nurse will discard the remaining ketamine and fentanyl in the
breath-actuated nebulizer.
A study investigator will approach each patient for written informed consent and Health
Insurance Portability and Accountability Act (HIPAA) authorization after the treating
emergency medicine physician has evaluated them and they meet the study eligibility
requirements. When English will not be the participant's primary language, a
language-appropriate consent form will be used, and non-investigator, hospital-employed,
trained interpreters, or licensed telephone interpreters will assist in the acquisition of
informed consent. Baseline pain score will be determined with an 11-point numeric rating
scale (0 to 10), described to the patient as "no pain" being 0 and "the worst pain
imaginable" being 10. A study investigator will record the patient's body weight and baseline
vital signs.
Study investigators will record pain scores, vital signs, and adverse effects at 15, 30, 60,
90, and 120 minutes. If patients report a pain numeric rating scale score of 5 or greater at
any of the aforementioned time points and request additional pain relief, intravenous (IV)
fentanyl at 0.75 mcg/kg will be administered as a rescue analgesic.
The ED pharmacist, research manager, and statistician will be the only ones with knowledge of
the study arm to which each participant will be randomized. The treating providers,
participants, and the data collection research team will be blind to the medication received.
All data will be recorded on data collection sheets, including patients' sex, demographics,
medical history, vital signs, adverse events, and need for rescue medication, etc., and
entered into SPSS (version 24.0; IBM Corp.) by the research manager. The research manager and
statistician (Michael Silver) will work independently of any data collection to develop the
randomization list, confirm the acquisition of written consent for all participants, and
conduct statistical analyses. The randomization will be Bock Randomization every 10 subjects.