drugset / Trial / NCT05518877

Low Dose Ketamine Infusion for Analgesia in the Emergency Department to Reduce Side Effects

NCT05518877 ↗

Phase 4 Completed 55 enrolled Summa Health System
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This will be an intent to treat prospective, double blind, double-dummy, randomized trial. Our primary objective is the reduction of side effects of sub dissociative dose ketamine given by slow intravenous (IV) infusion over 30 minutes vs. 15 minutes in the treatment of acute, severe pain in Emergency Department (ED) patients. The secondary objective will be to maintain adequate pain control (as defined by a Visual Analog Scale (VAS) score of ≤ 5cm) at 30 minutes for both groups.

Timeline

Start
2022-12-07
Primary completion
2025-04-02
Completion
2025-04-02

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry analysis (superiority test); Ketamine 15 Minutes vs Ketamine 30 Minutes; p <0.001; t-test, 2 sided NCT05518877 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 0.25 mg/kg Intravenous

Indications