search
Back to results

Protocolized vs Discretionary Use of Opioids in Acute Pain

Primary Purpose

Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hydromorphone
IV opioid
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Hydromorphone, acute pain, Protocolized, Efficacy, Safety

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Montefiore Medical Center Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Protocolized

Discretionary Care

Arm Description

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?"

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
January 19, 2009
Last Updated
May 17, 2018
Sponsor
Montefiore Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00825370
Brief Title
Protocolized vs Discretionary Use of Opioids in Acute Pain
Official Title
Protocolized vs Discretionary Use of Opioids in Acute Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2008 (Actual)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Hydromorphone, acute pain, Protocolized, Efficacy, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protocolized
Arm Type
Experimental
Arm Description
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?"
Arm Title
Discretionary Care
Arm Type
Active Comparator
Arm Description
Patients receive an IV opioid the type and dose of which is determined by the treating physician
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Other Intervention Name(s)
Dilaudid
Intervention Description
1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
Intervention Type
Drug
Intervention Name(s)
IV opioid
Other Intervention Name(s)
Discretionary care
Intervention Description
Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
Primary Outcome Measure Information:
Title
Percentage of Patients With Successful Treatment
Description
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
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes
Description
As defined by the percentage of patients who answer "no" to the question, "Do you want more pain medication?" at 15 minutes
Time Frame
15 min
Title
Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes
Description
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.
Time Frame
60 minutes
Title
Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes).
Description
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.
Time Frame
Up to 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew K Chang, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center Emergency Department
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Protocolized vs Discretionary Use of Opioids in Acute Pain

We'll reach out to this number within 24 hrs