Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures
- Registration Number
- NCT04061330
- Brief Summary
The purpose of this study is to establish the feasibility of initiating a ketamine pain control protocol in the emergency department for the treatment of acute pain in patients with long bone fractures and to compare the efficacy of the ketamine pain protocol to bolus morphine for pain control in the first 6 hours of patient stay in the emergency department.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- patients presenting to the ED with long bone fracture, open or closed.Long bone fractures include:humerus, radius, ulna, femur, tibia, fibula.
- Received morphine in the ED prior to enrollment
- Received ketamine any time prior to enrollment
- Glasgow Coma Scale(GCS) less than 15
- Transferred from other facility
- Other moderate to severe trauma injuries
- Contraindication to ketamine
- Cannot consent (no intubation, airway issues, hemodynamic instability)
- Prisoners
- Suspected and/or confirmed pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Opioid group Morphine - Ketamine Group Ketamine -
- Primary Outcome Measures
Name Time Method Clinical pain as assessed by the Numerical pain rating score (NPRS) 6 hours after initial administration of drug The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
- Secondary Outcome Measures
Name Time Method Score on Richmond Agitation-Sedation Scale (RASS) 6 hours after initial administration of drug The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
Physician satisfaction with analgesia end of treatment (about 6 hours after initial administration of drug) Physician satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.
Number of hypotension episodes 6 hours after initial administration of drug Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Number of participants with need for rescue benzodiazepine therapy in ketamine group for emergence phenomenon and dysphoria from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug) Number of participants with Adverse reactions from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug) Number of participants with need for rescue opioid therapy from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug) Patient satisfaction with analgesia end of treatment (about 6 hours after initial administration of drug) Patient satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.
Number of hypoxic episodes as measured with a continuous pulse oximeter 6 hours after initial administration of drug Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
Nursing satisfaction with analgesia end of treatment (about 6 hours after initial administration of drug) Nursing satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States