Phase 3
N=350
Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT01311895 ↗Enrolled (actual)
350
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Number of Patients With Satisfactory Pain Management at 60 Minutes — 112; 113 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- H2O (Drug); 1+1 (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Satisfactory Pain Management at 60 Minutes |
112; 113 | — |
| SECONDARY Mean Change in Pain Intensity From Baseline to 60 Minutes |
6.1; 5.7 | — |
| SECONDARY Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes |
112; 112 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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).
- Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature.
- ED attending physician's judgment that patient's pain warrants intravenous (IV) opioids
Exclusion Criteria
- 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.
- Prior adverse reaction to opioids.
- 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.
- Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
- Systolic Blood Pressure <90 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
- Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
- 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.
- 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
Data sourced from ClinicalTrials.gov (NCT01311895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.