Ketamine for Pain in the Emergency Department

May 11, 2023 updated by: Hackensack Meridian Health

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acute pain (including acute on chronic pain)
  • Pain score of moderate to severe (> 4/10) on the Numerical Rating Scale
  • Provider determines the patient requires intravenous ketamine for analgesia

Exclusion Criteria:

  • History of hypersensitivity to ketamine
  • Altered mental status
  • Psychiatric illness
  • Known history of renal or hepatic insufficiency
  • Acute head or eye injury
  • Suspected intracranial hypertension or mass
  • Headache as the chief complaint
  • Alcohol or drug abuse
  • Received an analgesic within the last four hours
  • History of congestive heart failure
  • History of aortic or brain aneurysm
  • Active Chest Pain
  • Porphyria
  • Active methadone treatment
  • Pregnant or breastfeeding

  • Signs of respiratory, hemodynamic, or neurologic compromise

    • Systolic blood pressure < 90 mmHg or > 180 mmHg
    • Heart rate < 50 beats per minute or > 150 beats per minute
    • Respiratory rate < 10 breaths per minute or > 30 breaths per minute
    • Glasgow Coma Score < 15
  • Previously received ketamine < 0.3 mg/kg IV for acute pain in the emergency department

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1: 0.1 mg/kg ketamine
0.1 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion.
Drug: Ketamine Injectable Product
Three different doses of ketamine will be administered.
Active Comparator: Arm 1: 0.2 mg/kg ketamine
0.2 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion.
Drug: Ketamine Injectable Product
Three different doses of ketamine will be administered.
Active Comparator: Arm 1: 0.3 mg/kg ketamine
0.3 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion.
Drug: Ketamine Injectable Product
Three different doses of ketamine will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: Within 2 hours post infusion completion

Pain score using Numerical Rating Scale (NRS) post ketamine infusion. The Numerical Rating Scale (NRS) ranges from 0-to-10 with 0 being no pain and lower numbers representing less pain, so in this case lower numbers will represent better outcomes.

Pain scores were reported at baseline and then at 15 min/30 min/60 min/90 min and 120 minutes post-infusion.
Within 2 hours post infusion completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Within 2 hours post infusion completion

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.

Adverse events were reported at baseline and then at 15 min/30 min/60 min/90 min and 120 minutes post-infusion.
Within 2 hours post infusion completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hackensack Meridian Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2019

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

March 28, 2019

First Submitted That Met QC Criteria

March 28, 2019

First Posted (Actual)

March 29, 2019

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2018-0970

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All study related materials will be kept confidential as required by law. Written documentation and computer files will remain in a locked or password protected location, with access given to those directly responsible for the conduct of the study. In addition, all information will be recorded in such a manner that subjects whose data is included in the analysis cannot be identified directly or through identifiers linked to the subjects.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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