Association Between Body Size and Response to Hydromorphone in ED

This study is currently recruiting participants.
Verified August 2012 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Information provided by (Responsible Party):
Adrienne Birnbaum, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01675778
First received: August 23, 2012
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

Pain is the most common complaint for patients presenting to the emergency department (ED). Inadequate pain relief is also a common problem in ED. Patients' pain perceptions and responses to intravenous opioids vary widely and are influenced by multiple factors. The objective of the current study is to examine the association between total body weight, BMI (body mass index) and clinical response to a fixed dose of intravenous hydromorphone.


Condition Intervention
Pain
Drug: Hydromorphone

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of Body Size and Composition on Response to Hydromorphone in ED Patients With Acute Pain

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Association between pain scale change and TBW/BMI [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Change in pain at 30 minutes and its relationship to TBW and BMI. Pain is measured with numerical rating scale(NRS)


Secondary Outcome Measures:
  • Association between change in pain at 15 minutes, [ Time Frame: 15 ] [ Designated as safety issue: Yes ]
    Secondary outcomes include change in pain at 15 minutes

  • pain treatment satisfaction at 30 min [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    patient satisfaction on pain treatment at 30 min

  • adverse events (low SatO2<92%, SBP< 90mmHg) [ Time Frame: 15 and 30 min ] [ Designated as safety issue: Yes ]
    adverse events

  • side effects (nausea, vomit, itching) [ Time Frame: 15 and 30 min ] [ Designated as safety issue: No ]
    side effects

  • influence of gender on the association between TBW, BMI and response to iv hydromorphone [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    influence of gender on the association between TBW, BMI and response to iv hydromorphone

  • influence of race/ethnicity, and genetic factors on the association between TBW, BMI and response to iv hydromorphone [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    influence of race/ethnicity on the association between TBW, BMI and response to iv hydromorphone

  • influence of genetic factors on the association between TBW, BMI and response to iv hydromorphone [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    influence of genetic factors on the association between TBW, BMI and response to iv hydromorphone

  • influence of age on the association between TBW/BMI and response to hydromorphone [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    influence of age on the association between TBW/BMI and response to hydromorphone will be examined


Other Outcome Measures:
  • Association between requirements for additional pain medications and TBW/BMI [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Association between requirements for additional pain medications and TBW/BMI


Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Hydromorphone
Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone. Pain scale change, patients' satisfaction, requirements for additional pain medications, side effects and adverse events will be recorded at 15 and 30 minutes. Patients' weight and height will be measured. Age, gender, and race/ethnicity will also be recorded. Blood draw for genetic study will be performed.
Drug: Hydromorphone
a fixed dose (1 mg) of hydromorphone will be given to the study subjects
Other Name: dilaudid

Detailed Description:

Pain is the most common complaint for patients presenting to the emergency department (ED). Morphine and hydromorphone are the two most commonly administrated intravenous opioid analgesics. However, a large inter-individual variation in the response to morphine or hydromorphone has been observed and a significant number of patients do not have satisfactory pain relief after receiving commonly administered doses of these two medications. Current studies have focused on investigating optimal strategies of intravenous opioid use for moderate and severe pain in the ED.

Contrary to the commonly recommended total body weight (TBW) based dosing strategy, a recent publication did not demonstrate a linear relationship between TBW and clinical response to morphine.

The ultimate goal of the research is to identify optimal methods of dosing opioids to alleviate pain in ED patients. The objective of this study is to examine the association between two measures of body size/body composition and response to a standard dose of hydromorphone. The null hypothesis is that there is no association between the measures of body size/composition and response to 1 mg hydromorphone, and thus no difference between the associations. If a strong association exists between TBW or BMI and pain response, it will lend support for the importance of taking body size or composition into account when making decisions about hydromorphone dosing in the ED. It will lay the groundwork for future studies of analgesic dosing. This is of particular importance given the increasing prevalence of obesity in the US and other developed nations.

Specific Aims:

  1. To test the association between analgesic response to a standard dose of hydromorphone and total body weight in ED patients with acute pain requiring intravenous opioid analgesia.
  2. To test the association between analgesic response to a standard dose of hydromorphone and BMI.
  3. To compare the associations between analgesic response to a standard dose of hydromorphone and the two measures of body size/composition, BMI and TBW.
  4. To assess whether the associations between response to hydromorphone and these measures of body size/composition are confounded or modified by gender, age, ethnicity and certain genetic polymorphisms.

The results of the current study will suggest whether body size or composition play a role in the clinical response to hydromorphone and may lay the groundwork for further studies to determine whether dosing should be modified to take these characteristics into account either continuously, e.g. 0.015 mg/kg hydromorphone or categorically (increasing doses by category of BMI).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English or Spanish speaking
  • Age 18 - 65 years old
  • Acute pain (less than 7 days in duration)
  • Pain with sufficient severity to warrant use of intravenous opioids in the judgment of ED attending physician

Exclusion Criteria:

  • Allergy to hydromorphone
  • Systolic blood pressure < 90 mm Hg
  • Room air oxygen saturation by pulse oximetry < 95% at baseline without supplemental oxygen
  • Alcohol or other drug intoxication as judged by the attending physician
  • Suspicion of drug seeking by ED physician
  • Use of opioids within the past 24 hours
  • Use of a monoamine oxidase inhibitor
  • Concurrent use of benzodiazepines
  • Presence of a chronic pain syndrome (such as sickle cell disease, peripheral neuropathy, diabetic neuropathy, or fibromyalgia)
  • History of COPD, sleep apnea, renal failure, liver disease
  • Pregnancy or breast feeding
  • Prior entry of patient in the study
  • Inability or unwillingness to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675778

Contacts
Contact: Adrienne Birnbaum, MD 718-918-5815 adrienne.birnbaum@nbhn.net
Contact: Shujun Xia, MD 718-918-5821 shujunxia@gmail.com

Locations
United States, New York
Jacobi Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Adrienne Birnbaum, MD    718-918-5815    adrienne.birnbaum@nbhn.net   
Contact: Shujun Xia, MD    718-918-5821    shujunxia@gmail.com   
Principal Investigator: Adrienne Birnbaum, MD         
North Central Bronx Hospital Recruiting
Bronx, New York, United States, 10467
Contact: Adrienne Birnbaum, MD    718-918-5815    adrienne.birnbaum@nbhn.net   
Contact: Shujun Xia, MD    718-918-5821    shujunxia@gmail.com   
Principal Investigator: Adrienne Birnbaum, MD         
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Adrienne Birnbaum, MD Jacobi Medical Center, Albert Einstein College of Medicine
  More Information

No publications provided

Responsible Party: Adrienne Birnbaum, Professor of Clinical Emergency Medicine, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01675778     History of Changes
Other Study ID Numbers: 2011-445
Study First Received: August 23, 2012
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
hydromorphone
acute pain
emergency department

Additional relevant MeSH terms:
Hydromorphone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 23, 2014