- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03714620
Sub-dissociative Dose Ketamine Dosing Study
A Randomized, Controlled Trial of Intravenous Sub-dissociative Ketamine at Two Doses for Analgesia in the Emergency Department
Study Overview
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Illinois
-
Maywood, Illinois, United States, 60153
- Loyola University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Shannon Lovett, MD, Loyola University Chicago, LUMC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Acute Pain
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- 211328
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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