Acute Pain
Conditions
Keywords
Ketamine, Acute Pain
Brief summary
Our goal is to study whether giving people low dose ketamine along with morphine when they come to the Emergency Department will help their pain more than giving morphine by itself. There have been many studies showing that low dose ketamine is safe and effective for pain control. Ketamine is frequently used for pain control in ambulances and helicopters transporting injured patients to the hospital and has also been used for pain control in people who have just had surgery. The investigators would like to see if low dose ketamine would be safe and effective for patients with pain in the Emergency Department. Patients are eligible for the study if they come to the Emergency Department and their treating physician decides to treat them with morphine (with certain exceptions such as pregnant patients and patients with eye injuries). They will be given information about participating in the study and if they agree, they will be given the study drug. The study drug will be either ketamine or salt water (saline). If patients continue to be in pain they will continue to receive doses of morphine just as they would if they were not in the study. If the treating physician feels that morphine alone is not enough, they will be free to choose another pain medication as they would normally.
Interventions
DRUGKetamine
0.3mg/kg ketamine
DRUGMorphine
Dosage of morphine determined by treating physician
DRUGplacebo
saline of same volume as appropriate weight based dose of ketamine
Sponsors
American College of Emergency Physicians
University of Arizona
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 100 Years
Healthy volunteers
No
Inclusion criteria
* Presenting to Emergency Department in acute pain * age 18 and over * determined to require morphine for pain control by treating physician
Exclusion criteria
* Patients presenting with headache or head injury * Patient with eye injury or eye pain * Nontraumatic chest Pain * Pregnant patients or women of childbearing potential * Patients allergic to morphine or ketamine * Patients with known history of narcotic/alcohol abuse or presenting for narcotic medication refill * Patients with hypertension: diastolic blood pressure \> 100 OR systolic blood pressure \> 180 * Patient whose pain is so severe that they are unable to give informed consent * Patients who have had bad experiences to prior hallucinations from any origin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Score | Baseline (zero minutes), 30 minutes and 1 hour after receiving study drug | Pain 0-10 with 0 being no pain and 10 being the worst pain |
Secondary
| Measure | Time frame |
|---|---|
| Total Amount of Morphine and Other Pain Medications Administered | Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours) |
| Number of Participants With Adverse Events | Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Morphine and Placebo Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy
Morphine: Dosage of morphine determined by treating physician
placebo: saline of same volume as appropriate weight based dose of ketamine | 10 |
| Morphine and Ketamine Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care
Ketamine: 0.3mg/kg ketamine
Morphine: Dosage of morphine determined by treating physician | 7 |
| Total | 17 |
Baseline characteristics
| Characteristic | Morphine and Ketamine | Total | Morphine and Placebo |
|---|---|---|---|
| Age, Customized > 18 years | 7 participants | 17 participants | 10 participants |
| Region of Enrollment United States | 7 participants | 17 participants | 10 participants |
| Sex/Gender, Customized Females and males | 7 Participants | 17 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 7 |
| other Total, other adverse events | 4 / 10 | 4 / 7 |
| serious Total, serious adverse events | 0 / 10 | 0 / 7 |
Outcome results
Primary
Numeric Pain Score
Pain 0-10 with 0 being no pain and 10 being the worst pain
Time frame: Baseline (zero minutes), 30 minutes and 1 hour after receiving study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Morphine and Placebo | Numeric Pain Score | time 0 | 6.9 score on a scale | Standard Deviation 2.9 |
| Morphine and Placebo | Numeric Pain Score | 30 min | 7.7 score on a scale | Standard Deviation 2 |
| Morphine and Placebo | Numeric Pain Score | 60 min | 6.8 score on a scale | Standard Deviation 1.6 |
| Morphine and Ketamine | Numeric Pain Score | 60 min | 4.9 score on a scale | Standard Deviation 2.7 |
| Morphine and Ketamine | Numeric Pain Score | time 0 | 7.3 score on a scale | Standard Deviation 1.4 |
| Morphine and Ketamine | Numeric Pain Score | 30 min | 3.7 score on a scale | Standard Deviation 2.8 |
Secondary
Number of Participants With Adverse Events
Time frame: Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Morphine and Placebo | Number of Participants With Adverse Events | 4 Participants |
| Morphine and Ketamine | Number of Participants With Adverse Events | 4 Participants |
Secondary
Total Amount of Morphine and Other Pain Medications Administered
Time frame: Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morphine and Placebo | Total Amount of Morphine and Other Pain Medications Administered | 9 mg | Standard Deviation 5.3 |
| Morphine and Ketamine | Total Amount of Morphine and Other Pain Medications Administered | 10.3 mg | Standard Deviation 5.9 |