Using nebulized ketamine and fentanyl to treat acute pain in the emergency department
Comparison of Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED: A Prospective, Randomized, Double-Blind Clinical Trial.
This study tests whether using a mist of ketamine or fentanyl can help adults in the emergency room with severe pain feel better when they can't take medicine through an IV.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Maimonides Medical Center Academic / other |
| Locations | 1 site (Brooklyn, New York) |
| Trial ID | NCT06364540 on ClinicalTrials.gov |
What this trial studies
This trial compares the effectiveness and safety of nebulized ketamine and nebulized fentanyl for treating acute pain in adult patients in the emergency department. Patients will be randomly assigned to receive either 0.75 mg/kg of nebulized ketamine or 3 mcg/kg of nebulized fentanyl using a breath-actuated nebulizer. The study aims to evaluate pain relief and side effects in patients with moderate to severe pain who are unable to receive intravenous medication. The trial will follow a double-blind methodology to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 64 experiencing acute pain with a pain score of 5 or higher.
Not a fit: Patients with conditions requiring urgent intervention or those with altered mental status may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide an effective non-invasive pain management option for patients in emergency settings.
How similar studies have performed: Previous studies have shown promising results with nebulized ketamine for pain management, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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 \<90 mmHg or \>180 mmHg, pulse rate \<50 beats/min or \>150 beats/min, and respiration rate \<10 breaths/min or \>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
Where this trial is running
Brooklyn, New York
- Maimonides Medical Center — Brooklyn, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sergey Motov, MD — Maimonides Medical Center
- Study coordinator: Antonios Likourezos, MA, MPH
- Email: alikourezos@maimo.org
- Phone: 718-283-6896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.