Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364540
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-04-05
Brief Title:
Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED
Sponsor:
Antonios Likourezos
Organization:
Maimonides Medical Center
Study Overview
Official Title:
Comparison of Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED A Prospective Randomized Double-Blind Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KETAFEN
Brief 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 075 mgkg 1 mgkg and 15 mgkg 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 15-4 mcgkg 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 075 mgkg dose of ketamine administered via breath-actuated nebulizer BAN to a dose of 3 mcgkg of fentanyl administered via breath-actuated nebulizer BAN in adult patients presenting to the ED with acute painful conditions
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 075 mgkg 1 mgkg and 15 mgkg 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 15-4 mcgkg 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 075 mgkg dose of ketamine administered via breath-actuated nebulizer BAN to a dose of 3 mcgkg of fentanyl administered via breath-actuated nebulizer BAN in adult patients presenting to the ED with acute painful conditions
Detailed Description:
This is a prospective randomized double-blind trial comparing the analgesic efficacy and safety of nebulized ketamine administered at 075 mgkg via BAN to nebulized fentanyl administered at 3 mcgkg 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 mcgkg is based on two randomized dose-finding clinical trials of acute pain where a one mcgkg dose was compared to a 3 mcgkg dose with resultant analgesic superiority of the 3 mcgkg dose 26 27 The dose of nebulized ketamine is based on the results of our own randomized clinical trial which showed that 075 mgkg of nebulized ketamine was as effective at relieving short-term pain in the ED as 1 mgkg and 15 mgkg 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 075 mgkg of ketamine or a BAN with 3 mcgkg 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 075 mcgkg 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 participants 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 patients 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 075 mcgkg 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 240 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
The on-duty ED pharmacist will prepare either a breath-actuated nebulizer BAN with 075 mgkg of ketamine or a BAN with 3 mcgkg 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 075 mcgkg 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 participants 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 patients 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 075 mcgkg 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 240 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None