Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone

NCT01311895 | Completed Phase 3 Results

• 1 other identifier: MMC 10-07-201
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare two opioid protocols ("H2O" and "1+1") for the treatment of acute severe pain in the emergency department. The investigators primary hypothesis is that the "H2O" protocol will be more efficacious than the "1+1" protocol in Emergency Department patients aged 21-64 years. The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes.

Conditions

Acute Pain

Keywords

acute; pain; emergency department; hydromorphone

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Satisfactory Pain Management at 60 Minutes

  The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes. This is defined as the number of patients who declined additional pain medication at 60 minutes.

  60 minutes

Secondary Outcomes (2)

• Mean Change in Pain Intensity From Baseline to 60 Minutes

  60 minutes

• Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes

  60 minutes

Study Arms (2)

H2O

EXPERIMENTAL

2 mg IV hydromorphone administered over 2-3 minutes as initial dose

Drug: H2O

1+1

EXPERIMENTAL

1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?"

Drug: 1+1

Interventions

H2O DRUG

2 mg IV hydromorphone

Also known as: Dilaudid

H2O

1+1 DRUG

1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"

Also known as: Dilaudid

1+1

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 21 years and less than 65 years: This is a study of non-elderly adult patients. In addition, patients aged 21 years and younger are automatically triaged to the Children's Emergency Department (ED).
• Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature.
• ED attending physician's judgment that patient's pain warrants intravenous (IV) opioids

You may not qualify if:

• Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.
• Prior adverse reaction to opioids.
• Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of 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, and peripheral neuropathies.
• Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
• Systolic Blood Pressure \<90 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
• Oxygen saturation \< 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
• Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
• CO2 measurement greater than 46: In accordance with standard protocol, three 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 3 subsets are as follows:
• All patients who have a history of chronic obstructive pulmonary disease (COPD)
• All patients who report a history of asthma together with greater than a 20 pack-year smoking history
• All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center Moses Division Emergency Department

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Acute Pain; 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. Andrew Chang
• Organization: Montefiore Medical Center

achang3@yahoo.com

718-920-6626

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 10, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 18, 2018
• Results First Posted: May 18, 2018

Record last verified: 2018-04

Locations

US (1)