Protocolized vs Discretionary Use of Opioids in Acute Pain

NCT00825370 | Completed Phase 3 Results

• 1 other identifier: MMC 0808278
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

We are testing whether patients who received protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later if the patients wants more) will have better pain relief and no more adverse events than patients receiving discretionary care, in which the patients receives whatever IV opioid the treating physician wants to give, in whatever dose.

Conditions

Pain

Keywords

Hydromorphone; acute pain; Protocolized; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Successful Treatment

  Successful treatment was defined as either declining additional pain medication when asked at 15 minutes or accepting additional pain medication at 15 minutes but then declining additional pain medication at 60 minutes

  60 minutes

Secondary Outcomes (3)

• Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes

  15 min

• Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes

  60 minutes

• Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes).

  Up to 60 minutes

Study Arms (2)

Protocolized

EXPERIMENTAL

1 mg IV 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?"

Drug: Hydromorphone

Discretionary Care

ACTIVE COMPARATOR

Patients receive an IV opioid the type and dose of which is determined by the treating physician

Drug: IV opioid

Interventions

Hydromorphone DRUG

1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later

Also known as: Dilaudid

Protocolized

IV opioid DRUG

Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.

Also known as: Discretionary care

Discretionary Care

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 21 to 64 years.
• Pain with onset within 7 days.
• Emergency Department attending physician's judgment that patient's pain warrants use of intravenous opioids.
• Normal mental status.

You may not qualify if:

• Prior use of methadone.
• Use of other opioids, tramadol, or heroin in the past seven days.
• Prior adverse reaction to morphine, hydromorphone, or other opioids.
• Chronic pain syndrome.
• Alcohol intoxication.
• Systolic Blood Pressure \< 90 mm Hg.
• Use of monoamine oxidase (MAO) inhibitors in past 30 days.
• Weight less than 100 pounds.
• Baseline room air oxygen saturation less than 95%.
• C02 measurement greater than 46: In accordance with a number of similar studies that we have performed, four 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 4 subsets are as follows:
• All patients who have a history of chronic obstructive pulmonary disease (COPD)
• All patients who have a history of sleep apnea
• 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 Emergency Department

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Pain; Acute Pain

Interventions

Hydromorphone; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Andrew Chang, MD, MS
• Organization: Department of Emergency Medicine, Albert Einstein College of Medicine

achang@montefiore.org

7189207464

Study Officials

• Andrew K Chang, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 19, 2009
• First Posted: January 21, 2009
• Study Start: October 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 12, 2018
• Results First Posted: April 19, 2018

Record last verified: 2018-05

Locations

US (1)