Protocolized vs Discretionary Use of Opioids in Acute Pain

Study Overview
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Brief Summary
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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.

Official Title
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Protocolized vs Discretionary Use of Opioids in Acute Pain

Conditions
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Pain

Intervention / Treatment
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* Drug: Hydromorphone
* Drug: IV opioid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydromorphone, acute pain, Protocolized, Efficacy, Safety