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Safety of Hydromorphone in Adult Patients Presenting to the Emergency Department With Acute Severe Pain

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ClinicalTrials.gov Identifier: NCT00305110
Recruitment Status : Completed
First Posted : March 21, 2006
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Chang, MD, Montefiore Medical Center

Brief Summary:
The purpose of this study is to determine the safety and speed of onset of 2mg intravenous hydromorphone (Dilaudid) in patients weighing at least 150 lbs presenting to the emergency department with acute severe pain

Condition or disease Intervention/treatment Phase
Acute Pain Drug: 2 mg IV hydromorphone Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Speed of Onset of a Fixed Dose of Intravenous Hydromorphone in the Treatment of Adult Patients Presenting to the Emergency Department With Acute Severe Pain
Study Start Date : January 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 2 mg IV hydromorphone
2 mg IV hydromorphone administered over 2-3 minutes
Drug: 2 mg IV hydromorphone
Other Name: Dilaudid




Primary Outcome Measures :
  1. Number of Participants Requiring Naloxone [ Time Frame: immediately after infusion, up to 120 minutes post infusion ]
    Naloxone is a reversal agent - a medication that reverses the effects of another. Hydromorphone is an opiate pain medication that acts as a depressant to the body, thereby slowing it down. A large slow down is dangerous, as it can cause the breathing rate to slow down too much and prevent enough oxygen from entering the body and reaching the brain, resulting in death. Naloxone is a medication that blocks the receptors binding opiate pain medication and reversing the body's reaction to the hydromorphone, allowing body processes to return to normal speeds, including the breathing rate. The use of naloxone in the study indicates that the participant received too much pain medication or reacted more strongly than the average person, requiring the rescue medication to reverse the negative effects. The number of participants who required naloxone is assessed.


Secondary Outcome Measures :
  1. Number of Participants Experiencing a Respiratory Rate Lower Than 12 Breaths Per Minute [ Time Frame: immediately after infusion, up to 120 minutes post infusion ]
    Normal respiratory rate ranges from 12 to 20 breaths per minute. The decreased respiration results in a decreased amount of oxygen entering the body and therefore low amount of oxygen supplied to the brain. Prolonged oxygen deprivation can result in injury or death. Respiratory rates lower than 12 breaths per minute is a sign of distress. Number of participants experiencing a respiratory rate lower than 12 breaths per minute is measured.

  2. Number of Participants Experiencing a Systolic Blood Pressure Less Than 90 mmHg [ Time Frame: Immediately after infusion, up to 120 minutes post infusion ]
    Normal systolic blood pressure is approximately 120 mmHg. A low systolic blood pressure indicates blood, and therefore oxygen, are not being distributed around the body properly. This leads to a decreased amount of oxygen for the body to use and can result in injury or death if prolonged or severe.

  3. Oxygen Desaturation Measured Over 2-hour Time Frame [ Time Frame: immediately after infusion, up to 120 minutes post infusion ]
    blood oxygen saturation less than 95% is considered oxygen desaturation. Blood oxygen saturation is normally above 95%. Oxygen desaturation of less than 90% is dangerous because there is less oxygen throughout the body for cellular energy. Prolonged or severe blood oxygen desaturation can result in injury or death.

  4. Oxygen Saturation Measured Over 2-hour Time Frame [ Time Frame: baseline to 120 minutes post infusion ]
    blood oxygen saturation is measured periodically from 1 minute to 120 minutes after the medication was infused



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age greater than 21 years
  2. Age less than 65 years of age
  3. Pain with onset within 7 days
  4. ED attending physician's judgment that patient's pain warrants use of morphine
  5. Normal mental status

Exclusion Criteria:

  1. Prior use of methadone
  2. Use of other opioids or tramadol within past seven days
  3. Prior adverse reaction to hydromorphone.
  4. Chronic pain syndrome
  5. Alcohol intoxication
  6. SBP <90 mm Hg
  7. Use of MAO inhibitors in past 30 days
  8. C02 measurement greater than 46

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): NCT00305110


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Andrew K Chang, MD Montefiore Medical Center

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Responsible Party: Andrew Chang, MD, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00305110     History of Changes
Obsolete Identifiers: NCT01006850
Other Study ID Numbers: MMC 0511307
First Posted: March 21, 2006    Key Record Dates
Results First Posted: August 20, 2018
Last Update Posted: August 20, 2018
Last Verified: August 2018

Keywords provided by Andrew Chang, MD, Montefiore Medical Center:
Pain
Acute
Emergency Department
Severe
Hydromorphone
Dilaudid
Adult

Additional relevant MeSH terms:
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Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents