A pRospective, Case-controlled Evaluation of oLIceridine for Moderate or sEVEre Pain in Patients With Acute Burn Injuries. (RELIEVE)

22-08748-FB

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.

2023-04-01

2023-09-30

2023-10-24

Completed

Early phase I

31

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will be a single-center, prospective, case-controlled trial. Intervention arm patients will be randomly matched 2:1 to a historical comparator, based on age, TBSA, number of surgeries, and opioid and illicit drug use histories', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 31, 'type': 'ACTUAL'}}

2023-10-26