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Clinical study on analgesic efficacy and safety of nalbuphine, a ?-receptor analgesic drug, in polytrauma patients

Clinical study on analgesic efficacy and safety of nalbuphine, a ?-receptor analgesic drug, in polytrauma patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078026
Enrollment
Unknown
Registered
2023-11-27
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

polytrauma

Interventions

T1 group:Add 100mg of nalbuphine to 50ml of normal saline at a concentration of 2mg/ml, and use a micropump pumping at 240ug/kg/h for continuous micropumping
T2 group:Add 1mg of remifentanil to 50ml of normal saline at a concentration of 20ug/ml, and use a micropump pumping at 1.2ug/kg/h for continuous micropumping
T3 group:(3)Add 100mg of nalbuphine to 50ml of normal saline at a concentration of 2mg/ml, and use a micropump pumping at 120ug/kg/h for continuous micropumping
add 1mg of remifentanil to 50ml of normal saline at a concentration of 20ug/ml, and use a micropump pumping at 0.6ug/kg/h for continuous micropumping
the two drugs are pumped simultaneously.

Sponsors

The Third Affiliated Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1: 18= Age =75 years old 2: Patients with polytrauma

Exclusion criteria

Exclusion criteria: (1) Allergies to opioids; (2) Pregnancy or lactation; (3) Patients With medical conditions that may affect the analgesia assessment; (4) Chronic opioid addiction or use of other analgesics for more than 3 months (5) Inability to obtain consent; (6) Patients automatically gave up treatment or died during the study.

Design outcomes

Primary

MeasureTime frame
Analgesia scores in each group;

Secondary

MeasureTime frame
Levels of TNF-a, IL-6, PCT, CRP, WBC and NEUTP in each group;Total analgesic drug use in each group;The adjustment of analgesic use in each group;Duration of mechanical ventilation;Length of stay in TSICU;Total length of stay;The incidence of adverse events incidence;Incidence of nausea and vomiting;Hypotension;Bradycardia (heart rate 100 beats/min);Respiratory depression (spontaneous breathing rate = 10 beats/min)/ apnea;Dizziness/headache;Pruritus and other adverse reactions;

Countries

China

Contacts

Public ContactZhengtao Gu

The Third Affiliated Hospital of Southern Medical University

yytao700@smu.edu.cn+86 136 3141 9057

Outcome results

None listed

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