Pre-hospital Nebulized Ketamine for Pain

• Status: Withdrawn
• Trial end date: 2021-07-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Antonios Likourezos
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.