Comparison of Nebulized Ketamine to Intravenous Sub-Dissociative Dose Ketamine for Pain
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
Ketamine is a non-competitive N-methyl-D-aspartate (NMDA)/glutamate receptor complex
antagonist that decreases pain by diminishing central sensitization, hyperalgesia, and
"wind-up" phenomenon at the level of the spinal cord (dorsal ganglion) and central nervous
system (1). Ketamine administration in sub-dissociative doses (SDK) of 0.1-0.3 mg/kg in
pre-hospital settings and in the ED results in effective pain relief in patients with acute
traumatic and non-traumatic pain, chronic non-cancer and cancer pain, and in patients with
opioid-tolerant pain by virtue of providing anti-hyperalgesia, anti-allodynia, and
anti-tolerance (2-4). Two commonly utilized routes of SDK administration in the ED include an
intravenous route (intravenous push dose or short infusion) and intranasal route.
In the situation when intravenous access is not readily available or unobtainable, and
intranasal route is not feasible, another non-invasive route of ketamine administration such
as inhalation via Breath-Actuated Nebulizer (BAN) is coming into the play. The BAN allows a
controlled patient-initiated delivery of analgesics in titratable fashion. Nebulized
administration of ketamine has been studied in the areas of acute postoperative pain
management (post-intubational sore throat), in anesthesia (pre-medication for general
anesthesia,) and in managing cancer pain, and status asthmaticus therapy.
However, our research team has published a case series of 5 patients receiving nebulized
ketamine for a variety of acute painful conditions and has recently completed a randomized
double-blind trial of 120 adult patients that evaluated analgesic efficacy and safety of
nebulized ketamine at three different dosing regimens for acute pain in the ED. Currently, we
are conducting two additional studies evaluating the role of nebulized ketamine in pediatric
ED and pre-hospital arena.
In this study the investigators hypothesize that intravenous sub-dissociative-dose ketamine
of 0.3 mg/kg will provide better analgesia at 30 min post-medication administration in
comparison to nebulized ketamine administered at 0.75 mg/kg. The primary outcome of this
trial is the comparative reduction in participant's pain scores at 30 minutes post medication
administration.