Pain, Acute
Conditions
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.
Interventions
DRUGKetamine
Initial bolus of ketamine 0.3 mg/kg IV (maximum 30 mg) followed by ketamine infusion of 0.25mg/kg/hr (maximum 25mg/kg/hr) for 6 hours or until patient leaves the emergency department (ED),whichever occurs first.
DRUGMorphine
Bolus doses of morphine 0.1 mg/kg (maximum 8 mg) intravenously every 2 hours for 6 hours or until patient leaves the ED, whichever occurs first.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* patients presenting to the ED with long bone fracture, open or closed.Long bone fractures include:humerus, radius, ulna, femur, tibia, fibula.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pain as assessed by the Numerical pain rating score (NPRS) | baseline | The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of hypotension episodes | 5 minutes after initial administration of drug | Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg |
| Score on Richmond Agitation-Sedation Scale (RASS) | 5 minutes 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. |
| 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) | — |
| 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 hypoxic episodes as measured with a continuous pulse oximeter | 5 minutes 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. |
| 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. |
| 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. |
| 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. |
| 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) | — |
Countries
United States
Outcome results
None listed