Clinical trial NCT03714620: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration
timeFrame: 30 minutes
Secondary outcomes:
measure: Change in Pain Score From Baseline to 15 Minutes
timeFrame: 15 minutes
measure: Change in Pain Score From Baseline to 60 Minutes
timeFrame: 60 minutes
measure: Number of Participants Who Need Additional Pain Medication at 30 Minutes
timeFrame: 30 minutes
measure: Number of Patients Who Need Rescue Medications at 60 Minutes
timeFrame: 60 minutes
measure: Adverse Effects at 30 Min
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola University Chicago, LUMC
name: Shannon Lovett, MD
role: PRINCIPAL_INVESTIGATOR
References: