Oliceridine in Patients With Acute Burn Injuries
NCT05465226 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2023-10-26
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.
Conditions
- Acute Pain
- Burns
- Adverse Drug Event
- Respiratory Depression
- Nausea and Vomiting, Postoperative
Interventions
- DRUG
-
Oliceridine
see arm description
- DRUG
-
Historical opioid use
Historical matched, control group in 2:1 ratio
Sponsors & Collaborators
-
University of Tennessee
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-01
- Primary Completion
- 2023-09-30
- Completion
- 2023-10-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
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