CompletedPhase 4

Oliceridine in Patients With Acute Burn Injuries

United States31 participantsStarted 2023-04-01

Plain-language summary

Pain after acute burn injury is complex with much still not understood. The primary mechanism is believed to be nociceptive, but is interwoven with aspects of somatogenic, neuropathic, and psychogenic pathways. As such, opioid receptor agonists are an essential component for pain management after burn injury. The majority of wound care and dressing changes are completed in non-intubated patients and rates of respiratory depression concerning. Oliceridine is a biased, selective MOR agonist approved for treatment of acute pain. To date there is no literature of use in patients with burn injuries. While it should be effective, efficacy and the potential for reduced adverse events need to be quantified. Current practice and guidelines, plead for better analgesia for patients with burn injuries.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1\) age ≥ 18 years old, * 2\) total body surface area (TBSA) burned \< 20% * 3\) deep partial thickness or full thickness burns admitted for possible or definitive surgical needs, * 4\) moderate or severe pain related to acute burns (NRS ≥ 4 out of 10) Exclusion Criteria: * 1\) Presence of inhalation injury, * 2\) Pregnant, * 3\) Incarcerated, * 4\) only initial admission, * 5\) known anaphylaxis to oliceridine or other opioids, * 6\) Patient or authorized representative unable or unwilling to consent, * 7\) known cocaine, methamphetamine, or opioid use history, * 8\) use of numeric rating scale (NRS) would be inaccurate or inappropriate * 9\) Significant hepatic dysfunction

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Analyze change in pain scores after initiation of oliceridine in patients with moderate or severe pain after acute burn injury

Timeframe: Baseline and every 3-4 hours as standard of care allows or study medication continued, up to 7 days

Trial details

NCT IDNCT05465226

SponsorUniversity of Tennessee

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-30

View on ClinicalTrials.gov More Acute Pain trials