Comparing Intravenous Hydromorphone to Usual Care

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01429298
• Date of registration: 02/09/2011
• Primary sponsor: Montefiore Medical Center
• Public title: Comparing Intravenous Hydromorphone to Usual Care
• Scientific title: Randomized Clinical Trial Comparing IV Hydromorphone to Usual Care
• Date of first enrolment: March 2010
• Target sample size: 350
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01429298
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age greater than 21 years and less than 65 years: This is a study of non-elderly
adult 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 warrants IV opioids: The
factors that influence the decision to use parenteral opioids are complex. 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) 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 maximize
the external validity of the role of opioids 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 an extensive 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,
since it most closely approximates the circumstances of clinical practice.

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. SBP <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 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. C02 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 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



Age minimum: 21 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pain

Intervention(s)

Drug: 2 mg IV hydromorphone

Drug: Usual care

Primary Outcome(s)

Difference in successful treatment at 30 minutes [Time Frame: 30 minutes]

Secondary ID(s)

MMC 09-11-346

Source(s) of Monetary Support

Please refer to primary and secondary sponsors