Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety

Shachar Shimonovich, Roy Gigi, Amir Shapira, Tal Sarig-Meth, Danielle Nadav, Mattan Rozenek, Debra West, Pinchas Halpern, Shachar Shimonovich, Roy Gigi, Amir Shapira, Tal Sarig-Meth, Danielle Nadav, Mattan Rozenek, Debra West, Pinchas Halpern

Abstract

Background: 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. The objective of this study was 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 (≥80 mm on 100 mm Visual Analog Scale [VAS]) were randomized to receive either 1.0 mg/kg IN ketamine, 0.1 mg/kg IV MO or 0.15 mg/kg IM MO. Pain relief and adverse effects were recorded for 1 h post-administration. The primary outcome was efficacy of IN ketamine compared to IV and IM MO, measured by "time-to-onset" (defined as a ≥15 mm pain decrease on VAS), as well as time to and degree of maximal pain reduction.

Results: The 3 study groups showed a highly significant, similar maximal pain reduction of 56 ± 26 mm for IN Ketamine, and 59 ± 22 and 48 ± 30 for IV MO and IM MO, respectively. IN Ketamine provided clinically-comparable results to those of IV MO with regards to time to onset (14.3 ± 11.2 v. 8.9 ± 5.6 min, respectively) as well as in time to maximal pain reduction (40.4 ± 16.3) versus (33.4 ± 18), respectively.

Conclusions: IN ketamine shows efficacy and safety comparable to IV and IM MO. Given the benefits of this mode of analgesia in emergencies, it should be further studied for potential clinical applications.

Trial registration: Retrospectively registered on 27 June 2016. ClinicalTrials.gov ID: NCT02817477.

Keywords: Analgesia; Intranasal ketamine; Mass casualty; Morphine; Trauma.

Figures

Fig. 1
Fig. 1
Participant Flow. The participant flow for this study shows randomization of 90 patients. Patients were lost to follow-up due to tests, imaging, and other interventions that necessitated that we halt follow-up. Patients were excluded due to dosing errors
Fig. 2
Fig. 2
Average Pain Reduction in 5 min intervals between groups. The average VAS score for each group was graphed along with standard deviations. Intranasal Ketamine and IV morphine showed similar pain reduction, with IM morphine showing slower pain reduction over time

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Source: PubMed

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