Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 5/20/2018 |
| Start Date: | January 2011 |
| End Date: | November 2011 |
Randomized Clinical Trial Comparing Two Protocols Using IV Hydromorphone
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.
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.
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
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