Skip to content

Study on the application value of oxalidine fumarate injection for analgesia in emergency pre-hospital patients with severe trauma

Study on the application value of oxalidine fumarate injection for analgesia in emergency pre-hospital patients with severe trauma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111494
Enrollment
Unknown
Registered
2025-10-31
Start date
2024-12-28
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe trauma

Interventions

Ketamine injection group:After patients who meet the enrollment conditions are enrolled (ketamine injection group): After completing the necessary pre-hospital first aid assessment and first aid measu
use the analgesic efficacy evaluation tool to evaluate pain treatment after 5 minutes: Pain Management Index: The evaluation of pain treatment and adjustment of methods can be dynamically managed acco
when the efficacy index is <50%, it indicates that the analgesic effect is poor [7,37]. If the pain intervention is ineffective, an additional dose of 0.3-0.5 can be added. mg/kg IV, and re-evaluate t
the pre-hospital treatment method is determined by the clinician. , until necessary rescue measures and/or relevant inspections are complete

Sponsors

Fushun County People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old and 16 points; 3. Patients with pain ratings of grade II or III on NRS or Wong Baker scales; 4. Obtain informed consent from patients or their families.

Exclusion criteria

Exclusion criteria: 1. Age under 18 years old, or age over 75 years old; 2. Pregnancy or lactation; 3. Using single oxidase inhibitors; 4. Severe and existing substantial liver disease accompanied by clinically significant portal hypertension, Child Pugh C-grade cirrhosis, or acute liver failure; 5. Patients with acute or chronic renal insufficiency requiring dialysis treatment; 6. Severe traumatic brain injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, status epilepticus, etc; 7. Patients with a history of alcohol or drug abuse; 8. Any situation that hinders the correct assessment of cognitive function, such as language and sensory disorders or mental disorders (language difficulties or organic dysfunction) and inability to complete the Wong Baker scale; 9. Unable to obtain informed consent or authorization; 10. Participate in other exploratory clinical trials within one month prior to screening; 11. Known allergies to opioid and ketamine drugs; 12. Patients with severe hemodynamic instability, severe shock, and multiple organ failure; 13. Patients with severe ARDS;

Design outcomes

Primary

MeasureTime frame
Percentage of pre hospital emergency time within the target analgesia range;Study the duration of onset of target analgesia during drug administration and the total dosage of the drug;

Secondary

MeasureTime frame
Adverse reaction incidence rate;

Countries

China

Contacts

Public ContactQiang Li

Fushun County People's Hospital

xiaoqiang0403@163.com+86 188 2887 7788

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026