Pain
Conditions
Keywords
analgesia, ketamine, pain
Brief summary
The aim of the study is to compare the safety & efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The investigators are also interested to investigate whether low-dose ketamine is a safe and effective alternative option to opioids for the acute treatment of pain in the Emergency Department. The agents that are available in the department includes acetaminophen, non-steroidal anti-inflammatory (NSAIDS) and opioids. In most cases, acetaminophen and NSAIDS are not adequate to manage acute pain crisis. There is also heightening concerns for increased opioid use or abuse by patients. Since the HCAPHS survey includes various questions which inquires about patient perception of pain management in the department, the investigators are interested in investigating the safety and efficacy of low-dose ketamine to as an alternative method to opioids for the acute management of pain. There has been limited, mostly observational pilot studies, published in the literature. Limited data in the literature have reported the incidence of nausea and vomiting ranged from 3-13%. All published literature administered low-dose ketamine as an intravenous push. To the best of our knowledge our study would be the first study to administer low-dose ketamine as a short bolus infusion to mitigate the incidence of nausea and vomiting. The investigators believe our study would provide important scientific data to fill the theoretical gap that low-dose ketamine at 0.3mg/kg/dose may be a safe and effective agent for acute pain management in an ED that is located in the center of a densely populated urban area.
Detailed description
The aim of the study is to compare the safety & efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The is a randomized double blind placebo controlled trial to investigate the effects of low dose ketamine and morphine versus placebo and morphine for the management of acute pain in the ED.
Interventions
DRUGKetamine
Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes
DRUGPlacebo
Normal saline 50ml, administered over 15 minutes
Sponsors
The Brooklyn Hospital Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients 18 years old and older presenting with acute generalized pain * Describes pain to be greater than or equal to 3 on the Visual Analogue Scale (VAS) * Provides informed consent
Exclusion criteria
* Patients who are admitted to the hospital * Severe hypertension(≥180/100) * Presence of or suspected for traumatic head injury with or without loss of consciousness * Presence of or suspected for myocardial ischemia * Presence of or suspected alcohol intoxication * Hemodynamic instability * History of schizophrenia * History of Sickle cell crisis / presenting with acute sickle cell crisis * History of or suspected recreational substance abuse * History of or suspected diagnosis of headache or migraine * History of or suspected diagnosis increase in intracranial/intraocular pressure * Known or suspected pregnancy * Allergy to ketamine or morphine * Administration of opioids in previous 4 hours * Patients with language barriers or in altered mental status who are unable to describe pain * Patients weighing over 166kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes | 15 minutes after administration of study intervention | Change from Baseline of Pain as described by Numeric Rating Scale (NRS) \[minimum:0, maximum 10\] at 15 minutes. Lower values indicate worst outcomes while higher values indicate better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | during the study period | Incidence or number of participants with adverse events. |
| Patient Satisfaction of Pain Control Based on a Likert Scale | At the end of study period | Patient satisfaction of pain control based on a Likert Scale at the end of study completion, an average of 90 minutes. Scores reported out of scale of 10, 10 being most satisfied and 1 being least satisfied. |
| Mean Consumption of Rescue Analgesia | at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes) | — |
| ED Length of Stay (Minutes) | throughout study completion | ED Length of stay (minutes) throughout study period |
Countries
United States
Participant flow
Recruitment details
This was a single-center, prospective, randomized, double-blind, placebo-controlled trial comparing the use of SDDK versus placebo as an adjunct therapy for moderate to severe acute pain in the ED. The study was conducted in a community teaching hospital with a level-2 trauma ED where more than 77,000 patients are treated annually.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes | 30 |
| Placebo Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Placebo: Normal saline 50ml, administered over 15 minutes | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Treatment | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 41 years STANDARD_DEVIATION 16 | 48 years STANDARD_DEVIATION 17 | 44 years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 5 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 25 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 2 / 30 | 4 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes
Change from Baseline of Pain as described by Numeric Rating Scale (NRS) \[minimum:0, maximum 10\] at 15 minutes. Lower values indicate worst outcomes while higher values indicate better outcomes.
Time frame: 15 minutes after administration of study intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes | 3.5 units on a scale |
| Placebo | Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes | 6.0 units on a scale |
Secondary
ED Length of Stay (Minutes)
ED Length of stay (minutes) throughout study period
Time frame: throughout study completion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | ED Length of Stay (Minutes) | 267 minutes | Standard Deviation 191 |
| Placebo | ED Length of Stay (Minutes) | 292 minutes | Standard Deviation 203 |
Secondary
Mean Consumption of Rescue Analgesia
Time frame: at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Mean Consumption of Rescue Analgesia | T15 | 0.23 milligrams | Standard Deviation 1.3 |
| Treatment | Mean Consumption of Rescue Analgesia | T75 | 0 milligrams | Standard Deviation 0 |
| Treatment | Mean Consumption of Rescue Analgesia | T45 | 0.07 milligrams | Standard Deviation 0.37 |
| Treatment | Mean Consumption of Rescue Analgesia | T90 | 0.48 milligrams | Standard Deviation 1.66 |
| Treatment | Mean Consumption of Rescue Analgesia | T30 | 0.37 milligrams | Standard Deviation 1.45 |
| Treatment | Mean Consumption of Rescue Analgesia | T105 | 0.55 milligrams | Standard Deviation 1.87 |
| Treatment | Mean Consumption of Rescue Analgesia | T60 | 0 milligrams | Standard Deviation 0 |
| Treatment | Mean Consumption of Rescue Analgesia | T120 | 0 milligrams | Standard Deviation 0 |
| Treatment | Mean Consumption of Rescue Analgesia | T5 | 0 milligrams | Standard Deviation 0 |
| Placebo | Mean Consumption of Rescue Analgesia | T120 | 0.42 milligrams | Standard Deviation 1.7 |
| Placebo | Mean Consumption of Rescue Analgesia | T5 | 0 milligrams | Standard Deviation 0 |
| Placebo | Mean Consumption of Rescue Analgesia | T15 | 0.14 milligrams | Standard Deviation 0.74 |
| Placebo | Mean Consumption of Rescue Analgesia | T30 | 0.28 milligrams | Standard Deviation 1.03 |
| Placebo | Mean Consumption of Rescue Analgesia | T45 | 0 milligrams | Standard Deviation 0 |
| Placebo | Mean Consumption of Rescue Analgesia | T60 | 0.22 milligrams | Standard Deviation 1.15 |
| Placebo | Mean Consumption of Rescue Analgesia | T75 | 0 milligrams | Standard Deviation 0 |
| Placebo | Mean Consumption of Rescue Analgesia | T90 | 0 milligrams | Standard Deviation 0 |
| Placebo | Mean Consumption of Rescue Analgesia | T105 | 0.42 milligrams | Standard Deviation 1.26 |
Secondary
Number of Participants With Adverse Events
Incidence or number of participants with adverse events.
Time frame: during the study period
Population: Nausea was reported in three patients who received placebo and one patient who received ketamine. Dreams was reported in 1 patient who received placebo and one patient who received ketamine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Number of Participants With Adverse Events | 2 participants |
| Placebo | Number of Participants With Adverse Events | 4 participants |
Secondary
Patient Satisfaction of Pain Control Based on a Likert Scale
Patient satisfaction of pain control based on a Likert Scale at the end of study completion, an average of 90 minutes. Scores reported out of scale of 10, 10 being most satisfied and 1 being least satisfied.
Time frame: At the end of study period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Patient Satisfaction of Pain Control Based on a Likert Scale | 8.57 units on a scale | Standard Deviation 2.1 |
| Placebo | Patient Satisfaction of Pain Control Based on a Likert Scale | 6.05 units on a scale | Standard Deviation 2.6 |