Acute Pain Clinical Trial
Official title:
Intranasal Ketamine for Acute Traumatic Pain in the Emergency Department: A Prospective, Randomized Clinical Trial of Efficacy and Safety
Introduction: Ketamine has been well studied for its efficacy as an analgesic agent.
However, intranasal (IN) administration of ketamine has only recently been studied in the
emergency setting.
Objective: To elucidate the efficacy and adverse effects of a sub-dissociative dose of IN
Ketamine compared to IV and IM morphine.
Methods: A single-center, randomized, prospective, parallel clinical trial of efficacy and
safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency
department (ED). A convenience sample of 90 patients aged 18-70 experiencing moderate-severe
acute traumatic pain (≥80mm on 100mm Visual Analog Scale [VAS]) were randomized to receive
either 1.0mg/kg IN ketamine, 0.1mg/kg IV MO or 0.15mg/kg IM MO. Pain relief and adverse
effects were recorded for 1 hour post-administration.
Primary Outcomes: The primary outcome was efficacy of IN ketamine compared to IV and IM MO,
measured by "time-to-onset" (defined as a ≥15mm pain decrease on VAS), as well as time to
and degree of maximal pain reduction.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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