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Evaluation of the safety and efficacy of dexibuprofen in improving fever symptoms in children aged 6 months to 3 years, multicenter post marketing clinical trial protocol

Evaluation of the safety and efficacy of dexibuprofen in improving fever symptoms in children aged 6 months to 3 years: a multicenter post marketing clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093489
Enrollment
Unknown
Registered
2024-12-05
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

respiratory tract infection

Interventions

Observers:Oral administration of 6mg/kg/time of D-ibuprofen, 3ml for individuals aged 6 months to 1 year, and 4ml/time for individuals aged 1 to 3 years
The daily dosage for children weighing less than 30kg should not exceed 300mg (25ml). Interval of 4-6 hours per use, medication should not exceed 4 times per day (28mg/kg).
control group:Oral ibuprofen (Meilin) 6mg/kg/time, 4ml for 1-3 years old

Sponsors

The Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 3 Years

Inclusion criteria

Inclusion criteria: ? The diagnosis of upper or lower respiratory tract infection is when the axillary temperature of the child is = 38.5 ? and = 40.5 ?; ? The patient is a hospitalized child aged = 6 months and = 3 years old; ? Not using any antipyretic or analgesic drugs within 6 hours of fever; ? Not using glucocorticoids within 24 hours of fever; ? No serious underlying diseases, such as congenital heart disease, asthma, tumors, blood disorders, liver, liver, and kidney dysfunction; ? Voluntarily participating in this study, the child's legal guardian signed an informed consent form, and the process of obtaining informed consent complied with GCP regulations Ding.

Exclusion criteria

Exclusion criteria: ? Those who have taken ibuprofen oral suspension or used preparations containing ibuprofen within 6 hours of fever; ? Those who have taken acetaminophen suspension or preparations containing acetaminophen components within 6 hours of fever; ? Those who have used traditional Chinese medicine with antipyretic ingredients within 6 hours of fever or used glucocorticoid within 24 hours; ? Children with rash or chickenpox ? Children with severe malnutrition; ? Patients with heart failure or other organ dysfunction during medical treatment; ? Those who show signs of dehydration or high fever crisis during medical treatment; ? Individuals at risk of high fever within 6 months prior to seeking medical attention; ? Patients with active digestive ulcers at the time of consultation; ? Individuals with potential bleeding tendency or active bleeding symptoms during medical treatment; ? Individuals who have previously been allergic to ibuprofen or acetaminophen drugs; Previously taken aspirin and other nonsteroidal antibiotics Patients with asthma, rhinitis or urticaria induced by inflammatory drugs; ? Individuals with a history of kidney, liver, lung, endocrine, blood, or heart diseases prior to seeking medical attention, who have completed treatment for less than 6 months; ? Individuals with central nervous system abnormalities during medical treatment; ? Type 1 or type 2 diabetes patients who are not under control at present; ? Children with symptoms such as tuberculosis, sepsis, rheumatic fever, typhoid fever, local suppurative lesions, and prolonged fever; ? Due to other uncertain factors, the researcher has determined that they are not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Difference in temperature change after 4 hours of administration;

Secondary

MeasureTime frame
Improvement in Comfort Level;Gastrointestinal symptom evaluation;Safety indicators;

Countries

china

Contacts

Public ContactYang Liu

The Second Affiliated Hospital of Nanchang University

ocean3166@yeah.net+86 137 6703 8359

Outcome results

None listed

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