Acute PainPhase 4RELIEVENCT05465226
Oliceridine in Patients With Acute Burn Injuries
A Phase 4 study testing Oliceridine and Historical opioid use in people with Acute Pain and Burns, run by University of Tennessee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain, Burns, Adverse Drug Event
- What is being tested?
- Oliceridine and Historical opioid use
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 24 Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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,
Show all 9Show fewer
- 7) known cocaine, methamphetamine, or opioid use history,
- 8) use of numeric rating scale (NRS) would be inaccurate or inappropriate
- 9) Significant hepatic dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A pRospective, Case-controlled Evaluation of oLIceridine for Moderate or sEVEre Pain in Patients With Acute Burn Injuries. (RELIEVE)
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.
Read the detailed description
Pain after acute burn injury is complex with much still not understood. After acute burn injury, both injured tissue and adjacent non-burned tissue, upregulate response to painful and non-painful stimulus (hyperalgesia and allodynia, respectively). 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. Currently, high-dose fentanyl, oxycodone, hydromorphone, and morphine are used at profound doses to mitigate pain associated with daily care of patients with burn injuries. The majority of wound care and dressing changes are completed in non-intubated patients and rates of respiratory depression concerning.
High-quality data is controversial or lacking on the best approach for multimodal analgesia. Additionally, limitations exist for prescribing and monitoring some agents. While a multimodal approach may lead to a reduction in acute or chronic pain, adding a handful of medicines to eliminate a single agent leads to exponentially more side effects, risk of adverse effects, drug interactions, and pill burden. Drugs targeting neuropathic pain delay neural processing and are accompanied by cognitive slowing and responsiveness, which increases fall risk and limits rehabilitation participation. Gabapentin and pregabalin efficacies are highly debated with variable dosing recommendations. Side effects are common and include dizziness, somnolence, confusion, vision loss, respiratory dysfunction, peripheral edema, gastrointestinal discomfort or irregularities, or asthenia. If effective, serotonin-norepinephrine reuptake inhibitors response can be delayed by weeks and are known to cause significant weight loss, dizziness, asthenia, sleep disorders, and gastrointestinal dysfunction. Acetaminophen can help reduce background pain, but is hepatotoxic, depletes glutathione, and can mask fever. Nonsteroidal anti-inflammatory drugs carry significant safety concerns, including cardiovascular events, platelet dysfunction, bleeding, gastrointestinal toxicity, and renal failure. Local anesthetics have limited efficacy and dissipate quickly. Peripheral nerve blocks have mostly been studied for donor site pain, and placement requires specialized skills. Ketamine can be extremely helpful, especially in non-naïve patients with high-opioid tolerances but is approved as a moderate sedative and many state laws limit who can prescribe and/or monitor its administration. While ketamine does not depress respiratory drive, it is a hallucinogen, pro-deliriogenic, pro-arrhythmogenic, and carries its own concerns for gastrointestinal irregularities and drug dependence.
Opioid agonists bind to the mu opioid receptor (MOR), triggering downstream signaling through either G-protein-coupled or β-arrestin pathways. While the G-protein pathway is primarily involved in analgesia, β-arrestin has been shown responsible for adverse events, especially respiratory depression and gastrointestinal dysfunction. Additionally, the β-arrestin pathway terminates G-protein activation and induces endocytosis of the receptor, which can lead to reduced analgesia or opioid tolerance. Oliceridine is a biased, selective MOR agonist approved for treatment of acute pain. Oliceridine has shown a 3-fold preferential pathway activation of G-protein over β-arrestin. As a result, subsequent clinical trials have resulted in improved analgesia over placebo and morphine, while significantly reducing adverse events. 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
- Being tested
- Oliceridine, Historical opioid use
- Medical subject headings
- Acute Pain, Burns, Drug-Related Side Effects and Adverse Reactions, Respiratory Insufficiency, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OliceridineDrug
see arm description
Historical opioid useDrug
Historical matched, control group in 2:1 ratio
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Historical opioid use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Monitor for adverse events
Measured: At least daily while taking study medication, up to 7 days
Establish a burn injury-specific half maximal effective concentration
Plasma samples to measure concentration and pair with numeric pain score captured for Outcome 1
Measured: Sparse sampling strategy with up to 6 samples taken over the 4-hour dosing scheme
Establish a burn injury-specific half-life
Plasma samples to measure concentrations and calculate elimination coefficient
Measured: Sparse sampling strategy with up to 6 samples taken over the 4-hour dosing scheme
Establish a burn injury-specific volume of distribution
Plasma samples to measure concentrations and calculate volume of distribution
Measured: Sparse sampling strategy with up to 6 samples taken over the 4-hour dosing scheme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Apr 2023
- Primary completion30 Sep 2023
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465226
- Sponsor's protocol ID
- 22-08748-FB
- Acronym
- RELIEVE
- Status last verified
- Oct 2023
- First submitted
- 22 Jun 2022
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
James DL, Jowza M. Principles of Burn Pain Management. Clin Plast Surg. 2017 Oct;44(4):737-747. doi: 10.1016/j.cps.2017.05.005. Epub 2017 Jul 15.
PubMed 28888299Romanowski KS, Carson J, Pape K, Bernal E, Sharar S, Wiechman S, Carter D, Liu YM, Nitzschke S, Bhalla P, Litt J, Przkora R, Friedman B, Popiak S, Jeng J, Ryan CM, Joe V. American Burn Association Guidelines on the Management of Acute Pain in the Adult Burn Patient: A Review of the Literature, a Compilation of Expert Opinion and Next Steps. J Burn Care Res. 2020 Nov 30;41(6):1152-1164. doi: 10.1093/jbcr/iraa120. No abstract available.
PubMed 32885252Thompson EM, Andrews DD, Christ-Libertin C. Efficacy and safety of procedural sedation and analgesia for burn wound care. J Burn Care Res. 2012 Jul-Aug;33(4):504-9. doi: 10.1097/BCR.0b013e318236fe4f.
PubMed 22079919Myers R, Lozenski J, Wyatt M, Pena M, Northrop K, Bhavsar D, Kovac A. Sedation and Analgesia for Dressing Change: A Survey of American Burn Association Burn Centers. J Burn Care Res. 2017 Jan/Feb;38(1):e48-e54. doi: 10.1097/BCR.0000000000000423.
PubMed 27606558Wibbenmeyer L, Oltrogge K, Kluesner K, Zimmerman MB, Kealey PG. An evaluation of discharge opioid prescribing practices in a burn population. J Burn Care Res. 2015 Mar-Apr;36(2):329-35. doi: 10.1097/BCR.0000000000000110.
PubMed 25680091Wibbenmeyer L, Eid A, Kluesner K, Heard J, Zimmerman B, Kealey GP, Brennan T. An Evaluation of Factors Related to Postoperative Pain Control in Burn Patients. J Burn Care Res. 2015 Sep-Oct;36(5):580-6. doi: 10.1097/BCR.0000000000000199.
PubMed 26335109Kaul I, Amin A, Rosenberg M, Rosenberg L, Meyer WJ 3rd. Use of gabapentin and pregabalin for pruritus and neuropathic pain associated with major burn injury: A retrospective chart review. Burns. 2018 Mar;44(2):414-422. doi: 10.1016/j.burns.2017.07.018. Epub 2017 Aug 16.
PubMed 28822592Wibbenmeyer L, Eid A, Liao J, Heard J, Horsfield A, Kral L, Kealey P, Rosenquist R. Gabapentin is ineffective as an analgesic adjunct in the immediate postburn period. J Burn Care Res. 2014 Mar-Apr;35(2):136-42. doi: 10.1097/BCR.0b013e31828a4828.
PubMed 23511293Jones LM, Uribe AA, Coffey R, Puente EG, Abdel-Rasoul M, Murphy CV, Bergese SD. Pregabalin in the reduction of pain and opioid consumption after burn injuries: A preliminary, randomized, double-blind, placebo-controlled study. Medicine (Baltimore). 2019 May;98(18):e15343. doi: 10.1097/MD.0000000000015343.
PubMed 31045775Meyer WJ 3rd, Nichols RJ, Cortiella J, Villarreal C, Marvin JA, Blakeney PE, Herndon DN. Acetaminophen in the management of background pain in children post-burn. J Pain Symptom Manage. 1997 Jan;13(1):50-5. doi: 10.1016/s0885-3924(96)00201-1.
PubMed 9029861Retrouvey H, Shahrokhi S. Pain and the thermally injured patient-a review of current therapies. J Burn Care Res. 2015 Mar-Apr;36(2):315-23. doi: 10.1097/BCR.0000000000000073.
PubMed 24823343Pal SK, Cortiella J, Herndon D. Adjunctive methods of pain control in burns. Burns. 1997 Aug;23(5):404-12. doi: 10.1016/s0305-4179(97)00029-6.
PubMed 9426910Yang C, Xu XM, He GZ. Efficacy and feasibility of opioids for burn analgesia: An evidence-based qualitative review of randomized controlled trials. Burns. 2018 Mar;44(2):241-248. doi: 10.1016/j.burns.2017.10.012. Epub 2017 Nov 21.
PubMed 29169696Ly E, Velamuri S, Hickerson W, Hill DM, Desai J, Tsui B, Herr M, Jones J. Approaching trauma analgesia using prolonged and novel continuous peripheral nerve blocks - A case report. Anesth Pain Med (Seoul). 2022 Jan;17(1):87-92. doi: 10.17085/apm.21029. Epub 2021 Jul 22.
PubMed 34784461MacPherson RD, Woods D, Penfold J. Ketamine and midazolam delivered by patient-controlled analgesia in relieving pain associated with burns dressings. Clin J Pain. 2008 Sep;24(7):568-71. doi: 10.1097/AJP.0b013e31816cdb20.
PubMed 18716494
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A pRospective, Case-controlled Evaluation of oLIceridine for Moderate or sEVEre Pain in Patients With Acute Burn Injuries. (RELIEVE)
- ClinicalTrials.gov ID
- NCT05465226
- Acronym / sponsor ID
- RELIEVE / 22-08748-FB
- Conditions
- Acute Pain, Burns, Adverse Drug Event, Respiratory Depression, Nausea and Vomiting, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pain after acute burn injury is complex with much still not understood. After acute burn injury, both injured tissue and adjacent non-burned tissue, upregulate response to painful and non-painful stimulus (hyperalgesia and allodynia, respectively). 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. Currently, high-dose fentanyl, oxycodone, hydromorphone, and morphine are used at profound doses to mitigate pain associated with daily care of patients with burn injuries. The majority of wound care and dressing changes are completed in non-intubated patients and rates of respiratory depression concerning.
High-quality data is controversial or lacking on the best approach for multimodal analgesia. Additionally, limitations exist for prescribing and monitoring some agents. While a multimodal approach may lead to a reduction in acute or chronic pain, adding a handful of medicines to eliminate a single agent leads to exponentially more side effects, risk of adverse effects, drug interactions, and pill burden. Drugs targeting neuropathic pain delay neural processing and are accompanied by cognitive slowing and responsiveness, which increases fall risk and limits rehabilitation participation. Gabapentin and pregabalin efficacies are highly debated with variable dosing recommendations. Side effects are common and include dizziness, somnolence, confusion, vision loss, respiratory dysfunction, peripheral edema, gastrointestinal discomfort or irregularities, or asthenia. If effective, serotonin-norepinephrine reuptake inhibitors response can be delayed by weeks and are known to cause significant weight loss, dizziness, asthenia, sleep disorders, and gastrointestinal dysfunction. Acetaminophen can help reduce background pain, but is hepatotoxic, depletes glutathione, and can mask fever. Nonsteroidal anti-inflammatory drugs carry significant safety concerns, including cardiovascular events, platelet dysfunction, bleeding, gastrointestinal toxicity, and renal failure. Local anesthetics have limited efficacy and dissipate quickly. Peripheral nerve blocks have mostly been studied for donor site pain, and placement requires specialized skills. Ketamine can be extremely helpful, especially in non-naïve patients with high-opioid tolerances but is approved as a moderate sedative and many state laws limit who can prescribe and/or monitor its administration. While ketamine does not depress respiratory drive, it is a hallucinogen, pro-deliriogenic, pro-arrhythmogenic, and carries its own concerns for gastrointestinal irregularities and drug dependence.
Opioid agonists bind to the mu opioid receptor (MOR), triggering downstream signaling through either G-protein-coupled or β-arrestin pathways. While the G-protein pathway is primarily involved in analgesia, β-arrestin has been shown responsible for adverse events, especially respiratory depression and gastrointestinal dysfunction. Additionally, the β-arrestin pathway terminates G-protein activation and induces endocytosis of the receptor, which can lead to reduced analgesia or opioid tolerance. Oliceridine is a biased, selective MOR agonist approved for treatment of acute pain. Oliceridine has shown a 3-fold preferential pathway activation of G-protein over β-arrestin. As a result, subsequent clinical trials have resulted in improved analgesia over placebo and morphine, while significantly reducing adverse events. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Oliceridine Arm | Experimental | Drug: OliceridineInitially, 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. |
| Historical control | Active comparator | Drug: Historical opioid useRetrospective, observational, historical control arm matched by age, TBSA, number of surgeries, and opioid and illicit drug use histories |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 1) Presence of inhalation injury,
- 2) Pregnant,
- 3) Incarcerated,
- 4) only initial admission,
- 5) known anaphylaxis to oliceridine or other opioids,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oliceridinesee arm description | Drug | Oliceridine Arm |
| Historical opioid useHistorical matched, control group in 2:1 ratio | Drug | Historical control |
Primary outcome
Analyze change in pain scores after initiation of oliceridine in patients with moderate or severe pain after acute burn injury
Time frame: Baseline and every 3-4 hours as standard of care allows or study medication continued, up to 7 days
Change in Numeric Rating Scale (0 - 10 with 10 being the worst) pain scores after initiation
4 secondary outcomes
Characterize adverse events associated with administration of oliceridine in patients with acute burn injury
Time frame: At least daily while taking study medication, up to 7 days
Establish a burn injury-specific half maximal effective concentration
Time frame: Sparse sampling strategy with up to 6 samples taken over the 4-hour dosing scheme
Establish a burn injury-specific half-life
Time frame: Sparse sampling strategy with up to 6 samples taken over the 4-hour dosing scheme
Establish a burn injury-specific volume of distribution
Time frame: Sparse sampling strategy with up to 6 samples taken over the 4-hour dosing scheme
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Background: PubMed 28888299James DL, Jowza M. Principles of Burn Pain Management. Clin Plast Surg. 2017 Oct;44(4):737-747. doi: 10.1016/j.cps.2017.05.005. Epub 2017 Jul 15.
- Background: PubMed 32885252Romanowski KS, Carson J, Pape K, Bernal E, Sharar S, Wiechman S, Carter D, Liu YM, Nitzschke S, Bhalla P, Litt J, Przkora R, Friedman B, Popiak S, Jeng J, Ryan CM, Joe V. American Burn Association Guidelines on the Management of Acute Pain in the Adult Burn Patient: A Review of the Literature, a Compilation of Expert Opinion and Next Steps. J Burn Care Res. 2020 Nov 30;41(6):1152-1164. doi: 10.1093/jbcr/iraa120. No abstract available.
- Background: PubMed 22079919Thompson EM, Andrews DD, Christ-Libertin C. Efficacy and safety of procedural sedation and analgesia for burn wound care. J Burn Care Res. 2012 Jul-Aug;33(4):504-9. doi: 10.1097/BCR.0b013e318236fe4f.
- Background: PubMed 27606558Myers R, Lozenski J, Wyatt M, Pena M, Northrop K, Bhavsar D, Kovac A. Sedation and Analgesia for Dressing Change: A Survey of American Burn Association Burn Centers. J Burn Care Res. 2017 Jan/Feb;38(1):e48-e54. doi: 10.1097/BCR.0000000000000423.
- Background: PubMed 25680091Wibbenmeyer L, Oltrogge K, Kluesner K, Zimmerman MB, Kealey PG. An evaluation of discharge opioid prescribing practices in a burn population. J Burn Care Res. 2015 Mar-Apr;36(2):329-35. doi: 10.1097/BCR.0000000000000110.
- Background: PubMed 26335109Wibbenmeyer L, Eid A, Kluesner K, Heard J, Zimmerman B, Kealey GP, Brennan T. An Evaluation of Factors Related to Postoperative Pain Control in Burn Patients. J Burn Care Res. 2015 Sep-Oct;36(5):580-6. doi: 10.1097/BCR.0000000000000199.
- Background: PubMed 28822592Kaul I, Amin A, Rosenberg M, Rosenberg L, Meyer WJ 3rd. Use of gabapentin and pregabalin for pruritus and neuropathic pain associated with major burn injury: A retrospective chart review. Burns. 2018 Mar;44(2):414-422. doi: 10.1016/j.burns.2017.07.018. Epub 2017 Aug 16.
- Background: PubMed 23511293Wibbenmeyer L, Eid A, Liao J, Heard J, Horsfield A, Kral L, Kealey P, Rosenquist R. Gabapentin is ineffective as an analgesic adjunct in the immediate postburn period. J Burn Care Res. 2014 Mar-Apr;35(2):136-42. doi: 10.1097/BCR.0b013e31828a4828.
- Background: PubMed 31045775Jones LM, Uribe AA, Coffey R, Puente EG, Abdel-Rasoul M, Murphy CV, Bergese SD. Pregabalin in the reduction of pain and opioid consumption after burn injuries: A preliminary, randomized, double-blind, placebo-controlled study. Medicine (Baltimore). 2019 May;98(18):e15343. doi: 10.1097/MD.0000000000015343.
- Background: PubMed 9029861Meyer WJ 3rd, Nichols RJ, Cortiella J, Villarreal C, Marvin JA, Blakeney PE, Herndon DN. Acetaminophen in the management of background pain in children post-burn. J Pain Symptom Manage. 1997 Jan;13(1):50-5. doi: 10.1016/s0885-3924(96)00201-1.
- Background: PubMed 24823343Retrouvey H, Shahrokhi S. Pain and the thermally injured patient-a review of current therapies. J Burn Care Res. 2015 Mar-Apr;36(2):315-23. doi: 10.1097/BCR.0000000000000073.
- Background: PubMed 9426910Pal SK, Cortiella J, Herndon D. Adjunctive methods of pain control in burns. Burns. 1997 Aug;23(5):404-12. doi: 10.1016/s0305-4179(97)00029-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oliceridine and Historical opioid use in people with Acute Pain and Burns, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze change in pain scores after initiation of oliceridine in patients with moderate or severe pain after acute burn injury (time frame: Baseline and every 3-4 hours as standard of care allows or study medication continued, up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05465226, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.