A Randomized, Controlled Trial of Intravenous Sub-dissociative Ketamine at Two Doses for Analgesia in the Emergency Department
Overview
- Phase
- Phase 4
- Intervention
- Ketamine
- Conditions
- Acute Pain
- Sponsor
- Loyola University
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Shannon Lovett
Associate Professor of Department of Emergency Medicine
Loyola University
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
Arms & Interventions
0.15 mg/kg IV Ketamine
Intervention: Ketamine
0.3 mg/kg IV Ketamine
Intervention: Ketamine
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of Participants Who Need Additional Pain Medication at 30 Minutes(30 minutes)
- Change in Pain Score From Baseline to 60 Minutes(60 minutes)
- Number of Patients Who Need Rescue Medications at 60 Minutes(60 minutes)
- Adverse Effects at 30 Min(30 minutes)
- Change in Pain Score From Baseline to 15 Minutes(15 minutes)