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A multi-center, randomized, and positive-drug parallel controlled prospective clinical study to evaluate the efficacy and safety of dexibuprofen in the treatment of children with fever caused by influenza

A multi-center, randomized, and positive-drug parallel controlled prospective clinical study to evaluate the efficacy and safety of dexibuprofen in the treatment of children with fever caused by influenza

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097383
Enrollment
Unknown
Registered
2025-02-18
Start date
2025-02-08
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Influenza

Interventions

Experimental group:Take dexibuprofen

Sponsors

The Seventh Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Children who have been signed by a parent or legal guardian on an informed consent form; (2) Age>=1 year and =38.2°C, <41°C, or discomfort and depressed mood due to fever; (4) White blood cell count (WBC) <=15×10^9/L or absolute neutrophil count <=10×10^9/L; (5) C-reactive protein (CRP) or hypersensitive C-reactive protein (hs-CRP) <=2 times the upper limit of the reference value.

Exclusion criteria

Exclusion criteria: 1 Those who have taken ibuprofen oral suspension or used preparations containing ibuprofen within 6 hours at the time of presentation; 2. Those who have taken acetaminophen suspension or preparations containing acetaminophen within 6 hours of presentation; 3. Those who have used proprietary Chinese medicines with antipyretic ingredients within 6 hours at the time of consultation; 4. Those who have clear foci or indications of bacterial infection, or/and suspected respiratory diseases caused by lower respiratory tract infection requiring hospitalization; 5 Children with severe malnutrition; 6. Patients with heart failure or other organ insufficiency at the time of consultation; 7. Those who have signs of dehydration or high fever crisis at the time of presentation; 8 Those who are at risk of high fever within 6 months prior to the visit; 9 Patients with active peptic ulcer at the time of presentation; 10. Those who have a potential bleeding tendency or active bleeding manifestations at the time of presentation; 11 Those who have been allergic to ibuprofen or acetaminophen drugs in the past; History of wheezing caused by aspirin and other nonsteroidal anti-inflammatory drugs Patients with wheezing, rhinitis or urticaria; 12 Those who have a history of kidney, liver, lung, endocrine, hematologic, and heart diseases before the visit, and have been treated less than 6 months after the end of treatment; 13 Those with central nervous system abnormalities at the time of consultation; 14 Patients with currently uncontrolled type 1 or type 2 diabetes mellitus; 15. Consider patients with fever caused by infection with other highly infectious pathogens (e.g., tuberculosis, novel coronavirus, etc.); 16. Those who are judged by the investigator to be unsuitable for participating in this study due to other uncertain factors.

Design outcomes

Primary

MeasureTime frame
Body temperature change within 1 hour of first dose;

Secondary

MeasureTime frame
Proportion of people with normal body temperature (=37.2?) within 2 hours of the first dose;The amount of body temperature change and the average time to normalize body temperature (=37.2?) within 4 hours of the first dose;Circulatory system conditions within 4 hours of first dose;Improvement in child comfort 4 hours after the first dose;Evaluation of gastrointestinal symptoms within 24 hours and 72 hours of first dose;

Countries

China

Contacts

Public ContactChun Chen

The Seventh Affiliated Hospital Sun Yat-sen University

chenchun@mail.sysu.edu.cn+86 13719003063

Outcome results

None listed

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