Pre-hospital Nebulized Ketamine for Pain
Withdrawn before enrolling · Phase 4
Conditions studied: Pain
In brief
In the situation when intravenous access is not readily available or unobtainable, or when prehospital delays to obtain intravenous access are not warranted, sub-dissociative dose ketamine can be administered via intranasal (IN) route. The data supporting IN is not set on the optimum intranasal dose (range 0.75-1 mg/kg) and frequencies of administration. In addition, IN administration of SDK for adult patients in the ED requires a highly concentrated solution that is not routinely stock in the ED. Hence, another non-invasive route exists such as nebulization via a Breath-Actuated Nebulizer which allows a controlled patient-initiated delivery of analgesics in titratable fashion. Nebulized administration of ketamine however, has only been studied in the areas of acute postoperative pain management, cancer palliation, and status asthmaticus therapy (ref). To our knowledge, there are no prospective randomized trials that evaluated a role of nebulized SDK role in managing acute pain due to extremity trauma in the prehospital arena. We aim to evaluate analgesic efficacy and safety of sub-dissociative dose ketamine administered prehospital via breath-actuated nebulizer at 1.0 mg/kg for patients with acute traumatic extremity injuries.
Key facts
- Study ID
- NCT04162028
- Run by
- Antonios Likourezos
- People needed
- 0
- Starts
- 2019-01-15
- Expected to finish
- 2021-07-28
- Last updated by the study team
- 2021-07-30
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients 18 years of age and older
- acute traumatic extremities injuries
- a score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.
You may not qualify if…
- Patients with altered mental status,
- allergy to ketamine, pregnant patients,
- weight greater than 100 kg,
- unstable vital signs (systolic blood pressure <90 or>180 mm Hg,
- pulse rate <50 or >150 beats/min,
- respiration rate <10 or >30 breaths/min),
- inability to consent,
- past medical history of alcohol or drug abuse
- schizophrenia.
Where it is running
- Maimonides Medical Center — Brooklyn, New York, United States
Full record on ClinicalTrials.gov
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