Titration of Intravenous Hydromorphone
Information source: Montefiore Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Severe Pain
Intervention: Hydromorphone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Montefiore Medical Center Official(s) and/or principal investigator(s): Andrew K Chang, MD, MS, Principal Investigator, Affiliation: Montefiore Medical Center
Summary
This is an exploratory, hypothesis-generating safety and efficacy study for patients who
come to the ER in acute (less than 7 days in duration) severe pain. Patients with chronic
pain will not be enrolled. Eligible patients will receive up to a maximum of 4 mg IV
hydromorphone over a 4 hour period. Hydromorphone will be given as 1 mg increments based on
how the patient responds to the question, "Do you want more pain medicine?". This question
will be asked repeatedly 30 minutes after the patient answers "no" or 30 minutes after the
most recent dose of IV hydromorphone (which occurs if the patient answers "yes"). Up to 10%
(approximately 30 patients) will serve as a pilot at the start of the study.
Clinical Details
Official title: Titration of Intravenous Hydromorphone in Adult Emergency Department Patients With Pain
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Frequency of different patterns of opioid request
Eligibility
Minimum age: 21 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 1. Age greater than 21 years: Patients under the age of 21 are automatically triaged
to the Children's Hospital at Montefiore Emergency Department, and hence cannot be
enrolled in this study.
2. Age less than 65 years: Patients age 65 and over will be excluded from this study
as the effects on opioids on the elderly may be different than in the non-elderly.
3. Pain with onset within 7 days: Pain within seven days is the definition of acute
pain that has been used in ED literature.
4. ED attending physician's judgment that patient's pain warrants use of morphine
5. Normal mental status: In order to provide measures of pain experienced the
patient needs to have a normal mental status. Orientation to person, place and time
will be used as an indicator of sufficiently normal mental status to participate in
the study.
Exclusion Criteria:
- 1. Prior use of methadone: the effect of methadone use on the perception of acute
pain is unknown and suspected to be altered. Similar to sickle cell patients and
chronic cancer patients, patients on methadone usually require significantly higher
doses of opioids to control their pain.
2. Use of other opioids or tramadol within past 24 hours: 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 hydromorphone: patients will be excluded if they state
that they have an allergy to hydromorphone.
4. Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months
result 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. Patients for whom the attending physician suspects is addicted to opioids:
patients will be excluded if the attending suspects the patient may be addicted to
opioids or seeking to obtain them for diversionary reasons, such as for monetary
profit or other illicit use.
6. Alcohol intoxication: the presence of alcohol intoxication as judged by the
treating physician may alter perception, report, and treatment of pain.
7. SBP <100 mm Hg: Hydromorphone can produce peripheral vasodilation that may result
in orthostatic hypotension or syncope.
8. Respiratory rate < 12/minute: Hydromorphone can cause respiratory depression.
9. Oxygen saturation <95% on room air: For this study, oxygen saturation must be 95%
or above on room air in order to be enrolled.
10. Heart rate < 60 beats/minute: Hydromorphone can cause bradycardia.
11. Use of MAO inhibitors in past 30 days: MAOs have been reported to intensify the
effects of at least one opioid drug causing anxiety, confusion and significant
respiratory depression or coma.
12. C02 measurement greater than 46: 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:
1. All patients who have a history of COPD
2. All patients who report a history of asthma together with greater than a 20
pack-year smoking history
3. All patients reporting less than a 20 pack-year smoking history who are having
an asthma exacerbation
Locations and Contacts
Montefiore Medical Center Moses Emegency Department, Bronx, New York 10467, United States; Recruiting Andrew K Chang, MD, MS, Email: achang3@yahoo.com Andrew K Chang, MD, MS, Principal Investigator
Additional Information
Starting date: June 2013
Last updated: July 1, 2013
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