Safety and Efficacy of Intravenous Hydromorphone in Elderly Emergency Department Patients With Acute Severe Pain
Information source: Montefiore Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Hydromorphone (Drug); Usual care (Drug)
Phase: Phase 4
Sponsored by: Montefiore Medical Center
The hydromorphone protocol is more effective than usual care in Emergency Department (ED)
patients age 65 years and older in terms of proportion who choose to forgo additional pain
medication within 60 minutes post-baseline in the two groups.
Official title: Safety and Efficacy of Intravenous Hydromorphone Using Incremental Doses of 0.5 mg in Elderly ED Patients With Acute Severe Pain
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Proportion with successful treatment
Minimum age: 65 Years.
Maximum age: N/A.
1. Age greater than or equal to 65 years: This is a study of elderly patients.
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 may warrant IV opioids: The
factors that influence the decision to use parenteral opioids are complex and
extensive. An approach that is commonly taken to address the issue of patient
selection in drug trials is to use a specific condition (e. g., renal colic) or
treatment (e. g., post-hysterectomy) that would generally be thought to be
appropriately treated with an opioid analgesic, thereby eliminating individual
judgment about eligibility for the study. However in order to assess the role of
opioids with the widest generalizability in the ED setting, the investigators decided
to enroll patients with a variety of diagnoses, all with a complaint of acute pain.
Opioids are not an appropriate treatment for all patients who present with a
complaint of pain (e. g., gastroenteritis, migraine). Therefore, unless there is a
restriction to patients with a specific diagnosis, either a comprehensive list of
diagnoses and situations in which opioids are indicated must be specified, or
clinical judgment needs to be used. The investigators have opted for the latter
4. Normal mental status: In order to provide measures of pain experienced the patient
needs to have a normal mental status. The investigators will use a 6-item screener
(Wilber 2008) as an indicator of sufficiently normal mental status to participate in
1. Prior use of methadone: the effect of methadone use on the perception of acute pain
is unknown and suspected to be altered. The investigators feel that the needs of
patients on methadone may exceed the dosage ceiling of 1 mg that will be used for
this study. Similar to sickle cell patients and chronic cancer patients, patients on
methadone usually require significantly higher doses of opioids to control their
pain. Thus, the investigators feel that it would be unethical to restrict the dose
that this subset of patients can receive.
2. Use of other opioids or tramadol within past seven days: to avoid introducing bias
related to opioid tolerance that may alter the response to the study medication
thereby masking the medication's effect.
3. Prior adverse reaction to opioids.
4. Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months
results in alteration in 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, migraine, and peripheral neuropathies.
5. Alcohol intoxication: the presence of alcohol intoxication as judged by the treating
physician may alter perception, report, and treatment of pain.
6. SBP <90 mm Hg: Opioids can produce peripheral vasodilation that may result in
7. Oxygen saturation <95% on room air: For this study, oxygen saturation must be 95% or
above on room air in order to be enrolled.
8. Use of 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.
9. C02 measurement greater than 46: In accordance with a similar study (04-12-360),
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 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
Locations and Contacts
Montefiore Emergency Department, Bronx, New York 10467, United States; Recruiting
Andrew Chang, MD, MS, Email: firstname.lastname@example.org
Starting date: July 2009
Last updated: September 6, 2011