Examining Analgesic Synergy and Efficacy in Trauma Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Buprenorphine, Oxycodone.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Examining Analgesic Synergy and Efficacy in Trauma Care-A Randomized, Control Study of Buprenorphine Versus Oxycodone in Multimodal Pain Control Regimens
Overview
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
- Drug Buprenorphine
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 - Drug Oxycodone
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)
Primary outcome measures
- The Numeric Rating Scale (NRS) Pain Scores [Time frame: Day 14]
Secondary outcome measures (5)
- Morphine equivalent measure (MME) [Time frame: Day 14]
- Number of doses of rescue narcotic [Time frame: Day 14]
- Length of hospital stay [Time frame: Day 14]
- Length of Intensive Care Unit stay length of Intensive Care Unit stay [Time frame: Day 14]
- Opiate prescription utilization post hospitalization (as MME) [Time frame: Day 14]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Identifiers
NCT: NCT07435077 · IRB00140421