Protocolized vs Nonprotocolized Treatment of Adult ED 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: Acute Pain
Intervention: Hydromorphone (Drug); Nonprotocolized (Drug)
Phase: Phase 3
Sponsored by: Montefiore Medical Center
Official(s) and/or principal investigator(s):
Andrew Chang, M.D., Principal Investigator, Affiliation: Montefiore Medical Center
Patients treated with protocolized pain management (1 mg of IV hydromorphone followed by an
additional 1 mg IV hydromorphone if the patient wants more) will have better pain relief and
no more adverse events than patients receiving non-protocolized pain management.
Official title: A Randomized Controlled Trial Comparing Protocolized Versus Non-protocolized Treatment of Adult ED Patients With Acute Severe Pain
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Patient reported change in pain intensity from initial administration of analgesics (baseline) to 30 minutes post-baseline.
Secondary outcome: Changes in pain intensity from baseline to other pain assessment times (5, 15, 30, 60 and 90 minutes post-baseline); pain relief, and desire for additional pain medication. Incidence of adverse events will also be used as a secondary outcome.
Minimum age: 21 Years.
Maximum age: 64 Years.
1. Age 21 to 64 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. Age 64 was selected as an upper range for inclusion because
substantial evidence supports age as being an important determinant of morphine
requirement over longer periods of time.
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 use of intravenous
opioids: The factors that influence the decision to use intravenous 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 IV
opioids with the widest generalizability in the ED setting, we 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 either a comprehensive list of
diagnoses and situations in which opioids are indicated must be specified, or
clinical judgment needs to be used. We have opted for the latter alternative.
4. 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
1. Prior use of methadone: the effect of methadone use on the perception of acute pain
is unknown and suspected to be altered.
2. Use of other opioids, tramadol, or heroin in the past seven days: to avoid
introducing bias related to opioid tolerance that may alter the response to
intravenous opioids thereby masking the effects of the medications administered.
3. Prior adverse reaction to morphine, hydromorphone, or other opioids: An exception
will be if the patient has received opioid medications in the past without adverse
event (i. e. a patient may state he is allergic to morphine but has received
hydromorphone in the past without any adverse effects)
4. Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months
resulting 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 may alter the perception,
report, and treatment of pain. Alcohol intoxication will be determined to exist as
judged by the treating physician.
6. Systolic BP < 90 mm Hg: Opioids produce peripheral vasodilation that may result in
orthostatic hypotension or syncope.
7. 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
depression of respiration or coma.
8. Weight less than 100 pounds: we are concerned that hydromorphone in doses up to 2 mg
may not be safe in patients weighing less than 100 lbs.
9. Baseline room air oxygen saturation less than 95%: since IV opioids may cause
respiratory depression and result in hypoxemia, we are excluding this subgroup of
10. C02 measurement greater than 46: In accordance with a similar study (04-12-360),
four 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 4 subsets are as follows:
1. All patients who have a history of COPD
2. All patients who have a history of sleep apnea
3. All patients who report a history of asthma together with greater than a 20
pack-year smoking history
4. All patients reporting less than a 20 pack-year smoking history who are having
an asthma exacerbation
Locations and Contacts
Montefiore Medical Center, Bronx, New York 10467, United States
Starting date: October 2007
Last updated: July 19, 2011