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Protocolized vs Nonprotocolized Treatment of Adult ED Patients With Acute Severe Pain

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ClinicalTrials.gov Identifier: NCT00627367
Recruitment Status : Completed
First Posted : March 3, 2008
Last Update Posted : July 20, 2011
Information provided by:
Montefiore Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Hydromorphone Drug: Nonprotocolized Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Protocolized Versus Non-protocolized Treatment of Adult ED Patients With Acute Severe Pain
Study Start Date : October 2007
Primary Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Protocolized
1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer "yes" to the question, "Do you want more pain medication?"
Drug: Hydromorphone
Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes
Other Name: Dilaudid
Active Comparator: Nonprotocolized
An IV opioid the type and dose of which will be determined by the treating clincian
Drug: Nonprotocolized
An IV opioid the type and dose of which will be determined by the treating clinician
Other Name: Usual Care

Primary Outcome Measures :
  1. Patient reported change in pain intensity from initial administration of analgesics (baseline) to 30 minutes post-baseline. [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 5, 15, 60, 90 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  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 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.
  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 patients.
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627367

United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Principal Investigator: Andrew Chang, M.D. Montefiore Medical Center

Responsible Party: Andrew Chang, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00627367     History of Changes
Other Study ID Numbers: MMC 0710359
First Posted: March 3, 2008    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by Montefiore Medical Center:
Acute Pain Emergency Department ED Hydromorphone Dilaudid Protocolized Nonprotocolized Usual Care

Additional relevant MeSH terms:
Acute Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents