NCT03896230

Ketamine for Pain in the Emergency Department

Comparison of Ketamine 0.1 mg/kg, 0.2 mg/kg, and 0.3 mg/kg Intravenous Doses for Acute Pain in the Emergency Department: A Prospective, Randomized, Double-blind, Active-controlled, Clinical Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Hackensack Meridian Health · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study will prospectively compare the mean Numerical Rating Scale (NRS) pain score reduction amongst three recommended dosing strategies of intravenous ketamine (0.1 mg/kg, 0.2 mg/kg, and 0.3mg/kg) for acute pain in the emergency department (ED).This study will also examine the frequency of adverse events secondary to ketamine including fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing or vision, mood changes, generalized discomfort, and hallucinations, changes in vital signs. Subgroups for exploratory analysis based on the need for rescue analgesia within two hours of ketamine administration, adequate pain relief, previous opioid tolerance, and age (adults \< 65 years old and \> 65 years old).

Detailed description

A literature review was performed that searched for randomized clinical trials involving ketamine IV boluses for acute pain in the Emergency Department. Studies involving continuous infusions or intranasal routes of ketamine administration were not included. Thirteen randomized clinical trials were identified meeting this criteria. None of these trials directly compared ketamine doses within the 0.1-0.3 mg/kg range for pain score reduction and adverse events. Many of these trials concluded with the recommendation that further studies were needed to evaluate the optimal dosing of ketamine for acute pain and determine which populations are most ideal for its use. This study will be the first to evaluate ketamine for acute pain in the emergency department at standard of care doses (0.1 mg/kg, 0.2 mg/kg, and 0.3 mg/kg IV) to determine which dose correlates with the most efficacy and safety. This study will include the following procedures: * Patient consent, screening, and enrollment will be performed by the treating resident or attending who will remain blinded * Patient will be assigned a subject number * Treating resident or attending will notify the ED pharmacist that a patient has been enrolled in the trial * ED pharmacist will notify the IV room and place the study drug order * Either the ED pharmacist or a pharmacy supervisor will randomize the subject based on the predetermined randomization list * Study drug will be prepared as 0.1 mg/kg, 0.2 mg/kg, or 0.3 mg/kg IV dose in a 100 mL solution of dextrose 5% or sodium chloride 0.9% * ED pharmacist will promptly deliver the study drug to the ED * Baseline vital signs will be assessed prior to starting the study drug infusion * Study drug will be administered via IV infusion over 20 minutes * Treating resident or attending will reassess the patient at 15 minutes from the end of infusion, at 30 minutes from the end of infusion, and then every 30 minutes for up to 120 minutes or until discharge, whichever is sooner

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	Ketamine Injectable Product	Three different doses of ketamine will be administered.

Timeline

• Start date: 2019-05-03
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2019-03-29
• Last updated: 2023-06-07
• Results posted: 2023-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study