Opioid Use Disorder
Conditions
Keywords
Acute Pain, Pain Control, Trauma Care
Brief summary
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.
Detailed description
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.
Interventions
DRUGBuprenorphine
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
DRUGOxycodone
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)
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients with injury to at least 2 body locations as defined by Abbreviated Injury Scale (AIS) scores (Head, Face, Neck, Chest, Abdomen/Pelvis, Spine, Upper Extremity, Lower Extremity, External)
Exclusion criteria
* Glasgow Coma Scale (GCS) \<15 - Patients may be included if their GCS improves to 15 within 24 hours of admission * Age \<18 years * Age ≥80years * Prisoners * Pregnant patients * Non-English speakers * Inability to provide consent * Home buprenorphine or methadone use * Home opioid use \>45 Morphine Milligram Equivalents (MME)/day * Allergy to any medication within the study or control arm * Patients undergoing treatment for alcohol withdrawal * History of cirrhosis requiring dose adjustment of Tylenol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Numeric Rating Scale (NRS) Pain Scores | Day 14 | 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"). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine equivalent measure (MME) | Day 14 | 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 |
| Number of doses of rescue narcotic | Day 14 | Number of doses of rescue narcotic |
| Length of hospital stay | Day 14 | Length of hospital stay |
| Length of Intensive Care Unit stay length of Intensive Care Unit stay | Day 14 | Length of Intensive Care Unit stay |
| Opiate prescription utilization post hospitalization (as MME) | Day 14 | 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 |
Countries
United States
Contacts
CONTACTD'Ann B Hershel, MS
PRINCIPAL_INVESTIGATORMatthew Painter, MD, FACS
Wake Forest University Health Sciences
Outcome results
None listed