Oliceridine in Patients With Acute Burn Injuries (RELIEVE)
Acute Pain, Burns, Adverse Drug Event
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
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
Sites / Locations
- Regional One HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Oliceridine Arm
Historical control
Initially, patients will receive oliceridine 1-3 mg IVP every 1-3 hours as needed for moderate or severe pain (NRS ≥ 4) with 1-3 mg every 1-3 hours for breakthrough pain. NRS will be assessed every 3-4 hours routinely. Rescue doses will be allowed per clinical discretion as oliceridine 1-3 mg every hour. Doses will be titrated according to patient response and clinical discretion. In settings where rapid analgesia is needed, such as the operating room, post-anesthesia care unit, emergency room, or hydrotherapy, oliceridine will be administered in 0.5-2 mg doses every 5 minutes as needed for moderate or severe pain, according to anesthesiologist or treating physician's discretion. For the purposes of the study oliceridine will not exceed 7 days of administration and patients will be transitioned from intravenous opioids to oral therapy and de-escalated from opioids, as soon as the team deems appropriate.
Retrospective, observational, historical control arm matched by age, TBSA, number of surgeries, and opioid and illicit drug use histories