At a glance
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Comparison of Nebulized Sub-dissociative Dose Ketamine at Three Different Dosing Regimens for Treating Acute Pain in the Pediatric ED: A Prospective, Randomized Double-Blind Trial
In Brief
A Phase 4 clinical trial evaluating Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg, Nebulized Sub-dissociative Dose Ketamine at 1 mg/kg, and 1 other intervention for Pain. Completed, enrolled 80 participants across 1 site.
Detailed Summary
In the situation when intravenous access is not readily available or unobtainable, sub-dissociative dose ketamine can be administered via intranasal route (IN). The data supporting intranasal route in pediatric patients is somewhat conflicting with regards to the optimum intranasal dose (range 0.75-1 mg/kg) and frequencies of administration. Hence, another non-invasive route such as nebulization via Breath-Actuated Nebulizer which allows a controlled patient-initiated delivery of analgesics in titratable fashion might be considered in the ED. Administration of fentanyl via BAN for pediatric patients presenting to the ED with acute traumatic musculo-skeletal injuries was found to be safe and effective and comparable to intravenous fentanyl and intravenous morphine. 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 a variety of acute and chronic painful conditions in the ED.
Study Details
Timeline
Interventions
Nebulized Sub-dissociative Dose Ketamine at 0.75 mg/kg
Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg.
Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg.