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New treatment option for Pain, Acute
Official title Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED
ClinicalTrials.gov ID: NCT06364540
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pain, acute.
Also referred to as Ketalar.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- 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
You likely can't join if
- 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
- weight greater than 100 kg
- patients presenting with head injury
See the full eligibility 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
- 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
- weight greater than 100 kg
- patients presenting with head injury
- unstable vital signs (systolic blood pressure \ 180 mmHg, pulse rate \ 150 beats/min, and respiration rate \ 30 breaths/min)
- inability to provide consent
- current medical history of alcohol or drug abuse
- administration of opioids or opioid antagonist/agonist within 4-6 hours prior to arrival and NSAIDs 6 hours prior to arrival to the t
The study team makes the final eligibility decision.
Where it's taking place
- Brooklyn, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brooklyn, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.