Association Between Body Size and Response to Hydromorphone in ED

NCT01675778 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2011-445
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pain

Keywords

hydromorphone; acute pain; emergency department

Outcome Measures

Primary Outcomes (2)

• Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment

  Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 30 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient.

  30 minutes post-treatment

• Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment

  Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 30 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI). The reported value represents the correlation coefficient.

  30 minutes post-treatment

Secondary Outcomes (16)

• Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment

  15 minutes post-treatment

• Pain Treatment Satisfaction Levels as Assessed by Self-report

  30 minutes post-treatment

• Number of Participants With Oxygen Saturation Level < 92%

  30 minutes post-treatment

• Number of Participants With Nausea

  30 minutes post-treatment

• Effect of Gender on the Correlation Between TBW and Change in Pain Intensity

  30 minutes post-treatment

Other Outcomes (1)

• Number of Participants Who Desired for More Analgesics

  30 minutes post-treatment

Study Arms (1)

Hydromorphone

OTHER

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

Interventions

Hydromorphone DRUG

a fixed dose (1 mg) of hydromorphone will be given to the study subjects

Also known as: dilaudid

Hydromorphone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (2)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

North Central Bronx Hospital

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Xia S, Chew E, Choe D, Hernandez L, Birnbaum A. No correlation between body size and hydromorphone analgesia in obese patients in ED. Am J Emerg Med. 2015 Oct;33(10):1522-3. doi: 10.1016/j.ajem.2015.07.020. Epub 2015 Jul 21. No abstract available.

  PMID: 26286816 DERIVED

MeSH Terms

Conditions

Pain; Acute Pain; Emergencies

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Shujun Xia
• Organization: Jacobi Medical Center

shujun.xia@nbhn.net

718-918-5800

Study Officials

• Adrienne Birnbaum, MD

  Jacobi Medical Center, Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: August 30, 2012
• Study Start: October 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-10

Locations

US (2)