Sub-dissociative Dose Ketamine Dosing Study

August 8, 2022 updated by: Shannon Lovett, Loyola University

A Randomized, Controlled Trial of Intravenous Sub-dissociative Ketamine at Two Doses for Analgesia in the Emergency Department

Goal is to determine if in adults presenting to the Emergency Department (ED) with moderate to severe acute pain, Ketamine administered at 0.15 mg/kg will provide similar pain relief to Ketamine administered at 0.3 mg/kg, with fewer adverse effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study investigators will enroll participants who present to the Emergency Department (ED) with moderate to severe acute pain, and require intravenous pain medication. Participants will be double-blinded and randomized to one of the two treatment groups.

Investigators aim to determine if ketamine 0.15 mg/kg IVPB is non-inferior to ketamine 0.3 mg/kg IVBP for the treatment of acute moderate to severe pain in the Emergency Department (ED). Study investigators hypothesize that in adults presenting to the ED with moderate to severe acute pain, SDK administered at 0.15 mg/kg will provide similar pain relief to SDK at 0.3 mg/kg, with reduced adverse effects.

Study Type

Interventional

Enrollment (Actual)

98

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

    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola 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

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults ages 18-59
  • Weight 45 - 115 kg
  • Acute abdominal, flank, back, musculoskeletal pain, or a headache
  • Onset of pain within 7 days
  • Pain score of 5 or more
  • Requiring intravenous analgesia
  • Hasn't been enrolled in this study previously

Exclusion Criteria:

  • Pregnancy
  • Breast-feeding
  • Altered mental status rendering the patient unable to consent to the study
  • Allergy to ketamine
  • Unstable vital signs (systolic blood pressure <90 or >180 mm Hg, pulse rate <50 or >150 beats/minute, and respiration rate <10 or >30 breaths/minute)
  • History of acute head or eye injury, seizure, intracranial hypertension
  • Chronic pain
  • Renal or hepatic insufficiency
  • Known alcohol or drug use disorder
  • Currently under influence of alcohol/opiates
  • Acute psychiatric illness

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: 0.15 mg/kg IV Ketamine
Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
Active Comparator: 0.3 mg/kg IV Ketamine
Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration
Time Frame: 30 minutes
Change in numerical pain score (NRS) from time 0 to time 30 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Score From Baseline to 15 Minutes
Time Frame: 15 minutes
Change in numerical pain score (NRS) from time 0 to time 15 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
15 minutes
Change in Pain Score From Baseline to 60 Minutes
Time Frame: 60 minutes
Change in numerical pain score (NRS) from time 0 to time 60 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
60 minutes
Number of Participants Who Need Additional Pain Medication at 30 Minutes
Time Frame: 30 minutes
Patient request for additional pain medications at 30 minutes post initiation of drug administration
30 minutes
Number of Patients Who Need Rescue Medications at 60 Minutes
Time Frame: 60 minutes
Patient request for additional pain medications at 60 minutes
60 minutes
Adverse Effects at 30 Min
Time Frame: 30 minutes
Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc.
30 minutes

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Shannon Lovett, MD, Loyola University Chicago, LUMC

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)

October 15, 2018

Primary Completion (Actual)

September 17, 2019

Study Completion (Actual)

September 17, 2019

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (Actual)

October 22, 2018

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Yes

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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