Oliceridine in Patients With Acute Burn Injuries

NCT05465226 | Completed Phase 4 FDA Drug

• 1 other identifier: 22-08748-FB
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  Change in Numeric Rating Scale (0 - 10 with 10 being the worst) pain scores after initiation

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

Secondary Outcomes (4)

• Characterize adverse events associated with administration of oliceridine in patients with acute burn injury

  At least daily while taking study medication, up to 7 days

• Establish a burn injury-specific half maximal effective concentration

  Sparse sampling strategy with up to 6 samples taken over the 4-hour dosing scheme

• Establish a burn injury-specific half-life

  Sparse sampling strategy with up to 6 samples taken over the 4-hour dosing scheme

• Establish a burn injury-specific volume of distribution

  Sparse sampling strategy with up to 6 samples taken over the 4-hour dosing scheme

Study Arms (2)

Oliceridine Arm

EXPERIMENTAL

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.

Drug: Oliceridine

Historical control

ACTIVE COMPARATOR

Retrospective, observational, historical control arm matched by age, TBSA, number of surgeries, and opioid and illicit drug use histories

Drug: Historical opioid use

Interventions

Oliceridine DRUG

see arm description

Oliceridine Arm

Historical opioid use DRUG

Historical matched, control group in 2:1 ratio

Historical control

Eligibility Criteria

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

You may qualify if:

• \) age ≥ 18 years old,
• \) total body surface area (TBSA) burned \< 20%
• \) deep partial thickness or full thickness burns admitted for possible or definitive surgical needs,
• \) moderate or severe pain related to acute burns (NRS ≥ 4 out of 10)

You may not qualify if:

• \) Presence of inhalation injury,
• \) Pregnant,
• \) Incarcerated,
• \) only initial admission,
• \) known anaphylaxis to oliceridine or other opioids,
• \) Patient or authorized representative unable or unwilling to consent,
• \) known cocaine, methamphetamine, or opioid use history,
• \) use of numeric rating scale (NRS) would be inaccurate or inappropriate
• \) Significant hepatic dysfunction

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

Regional One Health

Memphis, Tennessee, 38103, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Acute Pain; Burns; Drug-Related Side Effects and Adverse Reactions; Respiratory Insufficiency; Postoperative Nausea and Vomiting

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Chemically-Induced Disorders; Respiration Disorders; Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 19, 2022
• Study Start: April 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 24, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)