Protocolized vs Discretionary Use of Opioids in Acute Pain

Pain Clinical Trial

Official title:

Protocolized vs Discretionary Use of Opioids in Acute Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825370
• Other study ID #: MMC 0808278
• Status: Completed
• Phase: Phase 3
• Start date: October 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain

Intervention

Drug:
• Hydromorphone
1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
• IV opioid
Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.

Locations

Country	Name	City	State
United States	Montefiore Medical Center Emergency Department	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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