pediatric pain
Conditions
Interventions
Single-arm trial:Intravenous infusion of ibuprofen
Sponsors
Children's Hospital,Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Inclusion criteria
Inclusion criteria: 1. Inpatient; 2. Age: 6 months and above to 2 years and below; 3. Receiving non-cardiac surgery requires drug-based pain relief treatment; 4. For undergoing non-cardiac surgeries, patients need to receive drug-based pain relief treatment and obtain written informed consent from one of their parents or other guardians.
Exclusion criteria
Exclusion criteria: 1. Unable to establish an intravenous access; 2. Before administration, patients received treatment with aspirin, acetaminophen, diclofenac, celecoxib, etc. within 4 hours, or received ibuprofen treatment within 6 hours. 3. Received or is currently receiving systemic steroid hormone therapy within 72 hours prior to administration; 4. Any of the following situations apply: suffering from a neurological disorder related to pain sensation; suffering from chronic pain and requiring the daily use of painkillers; using opioid drugs within 24 hours before surgery; 5. Patients who have an allergic reaction (such as an allergic response and severe skin reaction) to the active ingredients of ibuprofen injection or any of its excipients; 6. Patients who experience asthma, urticaria or allergic-like reactions after taking aspirin or other non-steroidal anti-inflammatory drugs; 7. Platelet dysfunction, etc.; Has active gastrointestinal ulcers / bleeding, or has had a recurrence of ulcers / bleeding in the past; Has a history of gastrointestinal bleeding or perforation after using non-steroidal anti-inflammatory drugs; Is receiving full-dose anticoagulation therapy (excluding anticoagulants routinely given for medical procedures); 8. Comorbidities (any of the following conditions): Severe heart failure; Known liver or kidney diseases, and/or functional impairments (ALT or AST > 5 times the upper limit of normal, or bilirubin > 2.5 times the upper limit of normal; Scr > 176 µmol/L), including (but not limited to) dialysis, oliguria, impaired renal function or kidney transplantation, and/or receiving nephrotoxic drugs; Severe hemolytic anemia; Immunosuppression; Dehydration, diarrhea; Severe asthma; Patients undergoing perioperative treatment for coronary artery bypass grafting; Extracorporeal membrane oxygenation; Patients with congenital heart disease with unclosed ductus arteriosus. 9. Due to the imminent termination of life support or the severity of the illness, the expected lifespan is less than 14 days. 10. Having participated in a clinical trial of another investigational drug within 30 days prior to enrollment; 11. There are other factors that researchers consider as not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration and population pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactZhigang Gao
Children's Hospital,Zhejiang University School of Medicine
Outcome results
None listed