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Efficacy and Safety of Dexibuprofen in the Treatment of Acute Infection-Induced Fever in Children

Efficacy and Safety of Dexibuprofen in the Treatment of Acute Infection-Induced Fever in Children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104124
Enrollment
Unknown
Registered
2025-06-11
Start date
2025-06-16
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

Acute respiratory tract infection with fever

Interventions

Control group:Ibuprofen suspension is taken first, followed by dexibuprofen suspension
Test Group:Dexibuprofen suspension is taken first, followed by ibuprofen suspension

Sponsors

children's hospital of fudan university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Acute infection-induced fever in hospitalized children; 2. Children aged 1 to 6 years, inclusive, with no gender restrictions; 3. Axillary temperature >38.5°C and <40°C; 4. Normal renal function; 5. Children with acute fever within 3 days.

Exclusion criteria

Exclusion criteria: 1. Children with severe infection or those with septic shock due to various causes; 2. Children who have received corticosteroid or intravenous immunoglobulin (IVIG) treatment; 3. Children with immunodeficiency; 4. Children with autoimmune or rheumatic diseases; 5. Children with chronic diseases in active or progressive phases; 6. Children with confirmed malignancies; 7. Children who have undergone surgery within 3 days; 8. Children with fever within 3 days after vaccination; 9. Children who have used antipyretic medication within 6 hours; 10. Children who have used non-steroidal anti-inflammatory drugs (NSAIDs) within 6 hours; 11. Children with known allergies to the study drug; 12. Children deemed unsuitable by the investigator;

Design outcomes

Primary

MeasureTime frame
The temperature change difference 30 minutes after drug administration.;

Secondary

MeasureTime frame
The ratio of patients whose body temperature returned to normal (axillary temperature =37.5°C) within 1 hour and 2 hours after drug administration.;Safety;The time from drug administration until the body temperature drops to =37.5°C (axillary temperature);The temperature change difference 1 hour and 2 hours after drug administration.;

Countries

China

Contacts

Public ContactZeng Mei

children's hospital of fudan university

zengmeigao@163.com+86 21 6493 3276

Outcome results

None listed

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