Examining Analgesic Synergy and Efficacy in Trauma Care

NCT07435077 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB00140421
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Keywords

Acute Pain; Pain Control; Trauma Care

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Morphine equivalent measure (MME)

  Day 14

• Number of doses of rescue narcotic

  Day 14

• Length of hospital stay

  Day 14

• Length of Intensive Care Unit stay length of Intensive Care Unit stay

  Day 14

• Opiate prescription utilization post hospitalization (as MME)

  Day 14

Other Outcomes (2)

• Opiate dependence Risk checklist

  Day 14

• Cost of the medications used

  Day 14

Study Arms (2)

Control group

OTHER

Standard pain control regimen with oxycodone

Drug: Oxycodone

Study group

EXPERIMENTAL

Standard pain control regimen with buprenorphine

Drug: Buprenorphine

Interventions

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

Also known as: Buprenex, Suboxone, Subutex

Study group

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)

Also known as: standard pain regimen - acetaminophen - ketorolac - methocarbamol

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Acute Pain; Agnosia

Interventions

Buprenorphine; Buprenorphine, Naloxone Drug Combination; Oxycodone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone; Drug Combinations; Pharmaceutical Preparations; Codeine; Morphine Derivatives

Study Officials

• Matthew Painter, MD, FACS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

D'Ann B Hershel, MS

CONTACT

336-716-1659; Dann.Hershel@wfusm.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)