Protocolized vs Discretionary Use of Opioids in Acute Pain

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Hydromorphone; Drug: IV opioid

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Prior use of methadone.
2. Use of other opioids, tramadol, or heroin in the past seven days.
3. Prior adverse reaction to morphine, hydromorphone, or other opioids.
4. Chronic pain syndrome.
5. Alcohol intoxication.
6. Systolic Blood Pressure < 90 mm Hg.
7. Use of monoamine oxidase (MAO) inhibitors in past 30 days.
8. Weight less than 100 pounds.
9. Baseline room air oxygen saturation less than 95%.

10. 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:

    1. All patients who have a history of chronic obstructive pulmonary disease (COPD)
    2. All patients who have a history of sleep apnea
    3. All patients who report a history of asthma together with greater than a 20 pack-year smoking history
    4. All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Protocolized; 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; 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later; Other Names: Dilaudid
Active Comparator: Discretionary Care; Patients receive an IV opioid the type and dose of which is determined by the treating physician	Drug: IV opioid; Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.; Other Names: Discretionary care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes	As defined by the percentage of patients who answer "no" to the question, "Do you want more pain medication?" at 15 minutes	15 min
Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes	Patients who did not want pain medication determined by those who answered "no" to the question "do you want more pain medication?" at 60 minutes after treatment.	60 minutes
Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes).	Mean change in pain intensity between baseline and 15 minutes and between baseline and 60 minutes post treatment. Pain intensity is measured on a numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable"). The averages were calculated by finding the mean of change in pain intensity for each patient.	Up to 60 minutes

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Andrew K Chang, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: January 19, 2009
• First Submitted That Met QC Criteria: January 20, 2009
• First Posted (Estimate): January 21, 2009

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Safety; Efficacy; acute pain; Hydromorphone; Protocolized
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Hydromorphone
• Other Study ID Numbers: MMC 0808278