Pain
Conditions
Keywords
Hydromorphone, acute pain, Protocolized, Efficacy, Safety
Brief summary
We are testing whether patients who received protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later if the patients wants more) will have better pain relief and no more adverse events than patients receiving discretionary care, in which the patients receives whatever IV opioid the treating physician wants to give, in whatever dose.
Interventions
DRUGHydromorphone
1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
DRUGIV opioid
Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 21 to 64 years. 2. Pain with onset within 7 days. 3. Emergency Department attending physician's judgment that patient's pain warrants use of intravenous opioids. 4. Normal mental status.
Exclusion criteria
1. Prior use of methadone. 2. Use of other opioids, tramadol, or heroin in the past seven days. 3. Prior adverse reaction to morphine, hydromorphone, or other opioids. 4. Chronic pain syndrome. 5. Alcohol intoxication. 6. Systolic Blood Pressure \< 90 mm Hg. 7. Use of monoamine oxidase (MAO) inhibitors in past 30 days. 8. Weight less than 100 pounds. 9. Baseline room air oxygen saturation less than 95%. 10. C02 measurement greater than 46: In accordance with a number of similar studies that we have performed, four subsets of patients will have their CO2 measured using a handheld capnometer prior to enrollment in the study. If the CO2 measurement is greater than 46, then the patient will be excluded from the study. The 4 subsets are as follows: 1. All patients who have a history of chronic obstructive pulmonary disease (COPD) 2. All patients who have a history of sleep apnea 3. All patients who report a history of asthma together with greater than a 20 pack-year smoking history 4. All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Successful Treatment | 60 minutes | Successful treatment was defined as either declining additional pain medication when asked at 15 minutes or accepting additional pain medication at 15 minutes but then declining additional pain medication at 60 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes | 15 min | As defined by the percentage of patients who answer no to the question, Do you want more pain medication? at 15 minutes |
| Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes | 60 minutes | Patients who did not want pain medication determined by those who answered no to the question do you want more pain medication? at 60 minutes after treatment. |
| Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes). | Up to 60 minutes | Mean change in pain intensity between baseline and 15 minutes and between baseline and 60 minutes post treatment. Pain intensity is measured on a numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). The averages were calculated by finding the mean of change in pain intensity for each patient. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Protocolized 1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?
Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later | 167 |
| Discretionary Care Patients receive an IV opioid the type and dose of which is determined by the treating physician
IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well. | 171 |
| Total | 338 |
Baseline characteristics
| Characteristic | Total | Discretionary Care | Protocolized |
|---|---|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 12 | 42 years STANDARD_DEVIATION 13 | 42 years STANDARD_DEVIATION 11 |
| Location of pain Abdomen | 208 Participants | 95 Participants | 113 Participants |
| Location of pain Other | 130 Participants | 76 Participants | 54 Participants |
| Nausea | 106 Participants | 44 Participants | 62 Participants |
| Pain Intensity 10 | 189 Participants | 91 Participants | 98 Participants |
| Pain Intensity 3-7 | 46 Participants | 24 Participants | 22 Participants |
| Pain Intensity 8 | 54 Participants | 32 Participants | 22 Participants |
| Pain Intensity 9 | 49 Participants | 24 Participants | 25 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 90 Participants | 43 Participants | 47 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 224 Participants | 114 Participants | 110 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 8 Participants | 5 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 16 Participants | 9 Participants | 7 Participants |
| Region of Enrollment United States | 338 Participants | 171 Participants | 167 Participants |
| Sex: Female, Male Female | 205 Participants | 98 Participants | 107 Participants |
| Sex: Female, Male Male | 133 Participants | 73 Participants | 60 Participants |
| Vomiting | 92 Participants | 46 Participants | 46 Participants |
| Weight | 179 pounds STANDARD_DEVIATION 48 | 173 pounds STANDARD_DEVIATION 44 | 185 pounds STANDARD_DEVIATION 52 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 167 | 0 / 171 |
| other Total, other adverse events | 22 / 167 | 30 / 171 |
| serious Total, serious adverse events | 0 / 167 | 0 / 171 |
Outcome results
Primary
Percentage of Patients With Successful Treatment
Successful treatment was defined as either declining additional pain medication when asked at 15 minutes or accepting additional pain medication at 15 minutes but then declining additional pain medication at 60 minutes
Time frame: 60 minutes
Population: The discrepancy between the number of patients enrolled and randomized and the number of patients included in analysis is due to missing data (6 from Protocolized and 4 from Discretionary Care) and participants enrolled more than once (2 from Protocolized).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Protocolized | Percentage of Patients With Successful Treatment | 86.8 Percentage of Participants |
| Discretionary Care | Percentage of Patients With Successful Treatment | 76.6 Percentage of Participants |
Secondary
Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes).
Mean change in pain intensity between baseline and 15 minutes and between baseline and 60 minutes post treatment. Pain intensity is measured on a numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). The averages were calculated by finding the mean of change in pain intensity for each patient.
Time frame: Up to 60 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Protocolized | Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes). | 15 minutes | 4.90 units on a scale | Standard Deviation 3.1 |
| Protocolized | Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes). | 60 minutes | 5.32 units on a scale | Standard Deviation 3.1 |
| Discretionary Care | Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes). | 15 minutes | 4.55 units on a scale | Standard Deviation 3 |
| Discretionary Care | Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes). | 60 minutes | 4.66 units on a scale | Standard Deviation 3.1 |
Secondary
Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes
As defined by the percentage of patients who answer no to the question, Do you want more pain medication? at 15 minutes
Time frame: 15 min
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Protocolized | Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes | 73.7 Percentage of Participants |
| Discretionary Care | Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes | 66.7 Percentage of Participants |
Secondary
Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes
Patients who did not want pain medication determined by those who answered no to the question do you want more pain medication? at 60 minutes after treatment.
Time frame: 60 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Protocolized | Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes | 72.5 percentage of participants |
| Discretionary Care | Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes | 63.7 percentage of participants |