Protocolized vs Discretionary Use of Opioids in Acute Pain

Phase 3

Completed

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.

Recruitment & Eligibility

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:
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

Arm && Interventions

Group	Intervention	Description
Protocolized	Hydromorphone	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?"
Discretionary Care	IV opioid	Patients receive an IV opioid the type and dose of which is determined by the treating physician

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Successful Treatment	60 minutes	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

Name	Time	Method
Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes	15 min	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	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).	Up to 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.