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Influence of Body Size and Composition on Response to Hydromorphone in ED Patients With Acute Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03789500
Recruitment Status : Completed
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Information provided by (Responsible Party):
Shujun Xia, Albert Einstein College of Medicine

Brief Summary:
Current study is investigate the association between total body weight, body mass index and the clinical response to a fixed dose of intravenous hydromorphone.

Condition or disease Intervention/treatment Phase
Pain Conditions Drug: Hydromorphone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Body Size and Composition on Response to Hydromorphone in ED Patients With Acute Pain
Study Start Date : July 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: study arm Drug: Hydromorphone

Primary Outcome Measures :
  1. pain numerical rating scale change [ Time Frame: 30 minutes ]
    pain intensity was measured based on numerical rating scale, 0 -10, with 0 as no pain and 10 as the worst pain intensity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 to 65 years of age English or Spanish speaking presenting to the ED with pain of less than or equal to 7 days' duration judged by the ED attending physicians to require intravenous opioid analgesics

Exclusion Criteria:

  • inability or unwillingness to provide informed consent previous allergic reaction to hydromorphone systolic blood pressure less than 90 mmHg room air oxygen saturation by pulse oximetry < 95% at baseline alcohol or drug intoxication drug seeking behavior as judged by the attending physician use of other opioids or benzodiazepines within the past 24 hours use of a monoamine oxidase inhibitor in the past 30 days methadone use history of COPD, sleep apnea, renal failure, liver disease, or chronic pain syndrome (sickle cell disease, peripheral neuropathy, diabetic neuropathy, or fibromyalgia) pregnancy or breast feeding and previous enrollment in the same study

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Responsible Party: Shujun Xia, Principal Investigator, Albert Einstein College of Medicine Identifier: NCT03789500     History of Changes
Other Study ID Numbers: 2011-445
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Acute Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents