Back to resultsSub-dissociative Dose Ketamine Dosing Study
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
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
Sites / Locations
- Loyola University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
0.15 mg/kg IV Ketamine
0.3 mg/kg IV Ketamine
Arm Description
Outcomes
Primary Outcome Measures
Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration
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.
Secondary Outcome Measures
Change in Pain Score From Baseline to 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.
Change in Pain Score From Baseline to 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.
Number of Participants Who Need Additional Pain Medication at 30 Minutes
Patient request for additional pain medications at 30 minutes post initiation of drug administration
Number of Patients Who Need Rescue Medications at 60 Minutes
Patient request for additional pain medications at 60 minutes
Adverse Effects at 30 Min
Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03714620
Brief Title
Sub-dissociative Dose Ketamine Dosing Study
Official Title
A Randomized, Controlled Trial of Intravenous Sub-dissociative Ketamine at Two Doses for Analgesia in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
September 17, 2019 (Actual)
Study Completion Date
September 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The sequence will be generated using randomization permuted blocks of 2 and 4 patients, with the allocated dose revealed using an online randomization module within the REDCap data management system.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All study investigators, patients and clinicians except the clinical pharmacist will be blinded to the study treatment allocation. Treatment will be prepared and blinded by the ED clinical pharmacist.
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.15 mg/kg IV Ketamine
Arm Type
Active Comparator
Arm Title
0.3 mg/kg IV Ketamine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
Primary Outcome Measure Information:
Title
Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Change in Pain Score From Baseline to 15 Minutes
Description
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.
Time Frame
15 minutes
Title
Change in Pain Score From Baseline to 60 Minutes
Description
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.
Time Frame
60 minutes
Title
Number of Participants Who Need Additional Pain Medication at 30 Minutes
Description
Patient request for additional pain medications at 30 minutes post initiation of drug administration
Time Frame
30 minutes
Title
Number of Patients Who Need Rescue Medications at 60 Minutes
Description
Patient request for additional pain medications at 60 minutes
Time Frame
60 minutes
Title
Adverse Effects at 30 Min
Description
Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Lovett, MD
Organizational Affiliation
Loyola University Chicago, LUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Sub-dissociative Dose Ketamine Dosing Study
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