Using nebulized ketamine and fentanyl to treat acute pain in the emergency department

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.