Acute Pain
Conditions
Keywords
acute, pain, emergency department, hydromorphone
Brief summary
The purpose of this study is to compare two opioid protocols (H2O and 1+1) for the treatment of acute severe pain in the emergency department. The investigators primary hypothesis is that the H2O protocol will be more efficacious than the 1+1 protocol in Emergency Department patients aged 21-64 years. The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes.
Interventions
DRUGH2O
2 mg IV hydromorphone
DRUG1+1
1mg I 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?
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age greater than 21 years and less than 65 years: This is a study of non-elderly adult patients. In addition, patients aged 21 years and younger are automatically triaged to the Children's Emergency Department (ED). 2. Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature. 3. ED attending physician's judgment that patient's pain warrants intravenous (IV) opioids
Exclusion criteria
1. Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics. 2. Prior adverse reaction to opioids. 3. Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies. 4. Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception. 5. Systolic Blood Pressure \<90 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension. 6. Oxygen saturation \< 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled. 7. Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma. 8. CO2 measurement greater than 46: In accordance with standard protocol, three 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 3 subsets are as follows: * All patients who have a history of chronic obstructive pulmonary disease (COPD) * All patients who report a history of asthma together with greater than a 20 pack-year smoking history * All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Satisfactory Pain Management at 60 Minutes | 60 minutes | The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes. This is defined as the number of patients who declined additional pain medication at 60 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Pain Intensity From Baseline to 60 Minutes | 60 minutes | Pain intensity is measured in numerical rating scale (NRS) units from 0 (no pain) to 10 (worst pain imaginable). The change here represents the NRS score given by the patients at 60 minutes subtracted from the score at baseline, before treatment in the Emergency Department. |
| Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes | 60 minutes | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| H2O (2 mg IV Hydromorphone) 2 mg IV hydromorphone
H2O: 2 mg IV hydromorphone | 166 |
| 1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone) 1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the following question: Do you want more pain medication?
1+1: 1mg I 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? | 168 |
| Total | 334 |
Baseline characteristics
| Characteristic | Total | 1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone) | H2O (2 mg IV Hydromorphone) |
|---|---|---|---|
| Age, Continuous | 43 years | 42 years | 44 years |
| Location of pain Abdomen | 228 Participants | 112 Participants | 116 Participants |
| Location of pain Other | 106 Participants | 56 Participants | 50 Participants |
| Nauseated or vomited before receiving opioids in the Emergency Department (ED) No | 121 Participants | 63 Participants | 58 Participants |
| Nauseated or vomited before receiving opioids in the Emergency Department (ED) Yes | 213 Participants | 105 Participants | 108 Participants |
| Pain intensity 10 | 190 Participants | 92 Participants | 98 Participants |
| Pain intensity 3-7 | 54 Participants | 26 Participants | 28 Participants |
| Pain intensity 8 | 52 Participants | 28 Participants | 24 Participants |
| Pain intensity 9 | 38 Participants | 22 Participants | 16 Participants |
| Race/Ethnicity, Customized Black | 92 Participants | 44 Participants | 48 Participants |
| Race/Ethnicity, Customized Hispanic | 225 Participants | 116 Participants | 109 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 13 Participants | 5 Participants | 8 Participants |
| Region of Enrollment United States | 334 Participants | 168 Participants | 166 Participants |
| Sex: Female, Male Female | 210 Participants | 107 Participants | 103 Participants |
| Sex: Female, Male Male | 124 Participants | 61 Participants | 63 Participants |
| Weight | 184 lbs | 186 lbs | 180 lbs |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 166 | 0 / 168 |
| other Total, other adverse events | 56 / 166 | 53 / 168 |
| serious Total, serious adverse events | 0 / 166 | 0 / 168 |
Outcome results
Primary
Number of Patients With Satisfactory Pain Management at 60 Minutes
The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes. This is defined as the number of patients who declined additional pain medication at 60 minutes.
Time frame: 60 minutes
Population: The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following.~H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7).~1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| H2O (2 mg IV Hydromorphone) | Number of Patients With Satisfactory Pain Management at 60 Minutes | 112 Participants |
| 1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone) | Number of Patients With Satisfactory Pain Management at 60 Minutes | 113 Participants |
Secondary
Mean Change in Pain Intensity From Baseline to 60 Minutes
Pain intensity is measured in numerical rating scale (NRS) units from 0 (no pain) to 10 (worst pain imaginable). The change here represents the NRS score given by the patients at 60 minutes subtracted from the score at baseline, before treatment in the Emergency Department.
Time frame: 60 minutes
Population: The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following.~H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7).~1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| H2O (2 mg IV Hydromorphone) | Mean Change in Pain Intensity From Baseline to 60 Minutes | 6.1 units on a scale | Standard Deviation 3.1 |
| 1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone) | Mean Change in Pain Intensity From Baseline to 60 Minutes | 5.7 units on a scale | Standard Deviation 3 |
Secondary
Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes
Time frame: 60 minutes
Population: The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following.~H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7).~1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| H2O (2 mg IV Hydromorphone) | Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes | 112 Participants |
| 1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone) | Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes | 112 Participants |