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Traumatic injury is responsible for over 25 million (16%) Emergency Department visits and over 225,000 deaths each year per 2021 Center for Disease Control data. This is the 3rd leading cause of death in the US. Often, acute care for the injured patient requires administration of pain medication for the purposes of acute pain control from injury. The mainstay of treatment for pain control has historically involved opioid pain medication.
A different medication which has been used in place of full agonist opioids is a product known as buprenorphine, which was developed in the 1960's. This medication works as a partial agonist/antagonist of the µ opioid pain receptors. It has performed robustly in comparison to full opioid agonist (FAO) medications, and in a recent meta-analysis of this medication, it was responsible for reducing pain, less rescue analgesia use, and similar rates of adverse events in comparison to full opioid agonist therapy. This also concurrently lowered the amount of Morphine Milligram Equivalents (MME) used by the postoperative patients, although the achievement of lower pain scores is the significant finding. These data assert that buprenorphine is more efficacious than FAO in mitigating acute post op pain due to comparable analgesic effect and longer duration of action when compared to many other oral opioids.
This medication has been commonly used in patients with opioid abuse disorder and has shown improvements in specific patient outcome metrics when induction therapy is performed in hospital for patients with opioid use disorder (OUD). Further, continuation of buprenorphine for patients taking the medication as an outpatient for acute pain control has been shown to be safe, and to have similar efficacy to discontinuation in favor of standard pain regimen therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | Standard pain control regimen with oxycodone |
|
| Study group | Experimental | Standard pain control regimen with buprenorphine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine | Drug | 2 mg every 6 hours prn for moderate to severe pain If after 2 doses this is insufficient, switch to 4 mg Q6 hours as needed IV buprenorphine 150 mcg Q6 hours for breakthrough pain |
| Measure | Description | Time Frame |
|---|---|---|
| The Numeric Rating Scale (NRS) Pain Scores | The Numeric Rating Scale (NRS) is an 11-point, self-reported measure of pain intensity ranging from 0 ("no pain") to 10 ("worst imaginable pain"). | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine equivalent measure (MME) | Morphine equivalent measure (MME) - Morphine Milligram Equivalents (MME) are a standardized unit used by clinicians to calculate the total daily potency of all opioid medications a patient is taking relative to morphine | Day 14 |
| Number of doses of rescue narcotic |
| Measure | Description | Time Frame |
|---|---|---|
| Opiate dependence Risk checklist | This will be assessed based upon how much opiate the patient has required post hospitalization, as well as the Community (COMM) assessment which will stratify risk of opiate dependence. | Day 14 |
| Cost of the medications used |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| D'Ann B Hershel, MS | Contact | 336-716-1659 | Dann.Hershel@wfusm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Painter, MD, FACS | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D059787 | Acute Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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Subjects will be administered the standard pain control regimen, which uses a combination of pain medications for pain control after injury with oxycodone as one of the components, or the standard pain control regimen with buprenorphine in place of the oxycodone medication. The remainder of the trauma care will be similar between participants.
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Participant
|
| Oxycodone | Drug | 1000 mg acetaminophen every 6 hours (unless <60 kg = 15 mg/kg Q6 hours) IV ketorolac 15 mg Q6 hours x 48 hours; Celebrex 200 mg twice a day after 500 mg methocarbamol three times a day If fail conservative study regimens after 24 hours, may switch to a PCA or consider other analgesic regimens (ketamine, epidural, etcetera) |
|
|
Number of doses of rescue narcotic |
| Day 14 |
| Length of hospital stay | Length of hospital stay | Day 14 |
| Length of Intensive Care Unit stay length of Intensive Care Unit stay | Length of Intensive Care Unit stay | Day 14 |
| Opiate prescription utilization post hospitalization (as MME) | Morphine equivalent measure (MME) - Morphine Milligram Equivalents (MME) are a standardized unit used by clinicians to calculate the total daily potency of all opioid medications a patient is taking relative to morphine | Day 14 |
the study will assess the cost of the medications used (cost per dose x number of doses)
| Day 14 |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009270 | Naloxone |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |