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Efficacy and Safety of Dexibuprofen Oral Suspension for Fever Treatment in Children with Acute Lower Respiratory Tract Infections: A Multicenter, Randomized Controlled Trial

Efficacy and Safety of Dexibuprofen Oral Suspension for Fever Treatment in Children with Acute Lower Respiratory Tract Infections: A Multicenter, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101700
Enrollment
Unknown
Registered
2025-04-28
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-05-05

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

Conditions

lower respiratory tract infection with fever

Interventions

Experimental group:On the basis of conventional physical cooling methods (including warm water compresses, fever-reducing patches, reducing clothing, etc.), administer a single dose of 4 mg/kg dextroi
Control group:On the basis of conventional physical cooling methods (including warm water compresses, fever-reducing patches, reducing clothing, etc.), administer 5 mg/kg of ibuprofen oral suspension

Sponsors

Department of Pediatrics, Xijing Hospital, the Fourth Military Medical University, Xi'an, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 9 Years

Inclusion criteria

Inclusion criteria: All participants must meet the following inclusion criteria: (1) Children whose parents or legal guardians have signed the informed consent form; (2) Patients aged 1–9 years, regardless of gender; (3) Meeting the diagnostic criteria for acute lower respiratory tract infections as outlined in Zhu Futang's Practical Pediatrics, including acute bronchitis and pneumonia (bronchopneumonia, lobar pneumonia); (4) Presenting with fever symptoms, with an axillary temperature between 38.5°C and 41°C; (5) The time since the first onset of clinical symptoms in this episode is <=7 days.

Exclusion criteria

Exclusion criteria: The following conditions will exclude participants from the clinical trial: (1) Use of antipyretic drugs within the past 6 hours; (2) Use of hormonal medications within the past 72 hours; (3) Severe pneumonia; (4) Severe malnutrition; (5) Accompanied by heart failure or other organ dysfunction; (6) Signs of dehydration; (7) History of hyperthermia crisis within the past 6 months; (8) Gastrointestinal diseases (e.g., ulcerative colitis, Crohn's disease, etc.); (9) Bleeding tendency; (10) Allergy to this class of drugs; asthma, rhinitis, or urticaria induced by aspirin or other non-steroidal anti-inflammatory drugs; (11) Chronic diseases of the liver, kidneys, endocrine system (e.g., uncontrolled diabetes, etc.), blood, heart, respiratory system, genetic metabolic disorders, or other critical illnesses; (12) Central nervous system diseases; (13) Rheumatic or autoimmune diseases (e.g., systemic lupus erythematosus, mixed connective tissue disease, etc.); (14) Participation in other drug clinical trials within 1 month before screening; (15) Other conditions deemed unsuitable for participation by the investigator.

Design outcomes

Primary

MeasureTime frame
Change in body temperature 4 hours after administration;

Secondary

MeasureTime frame
Proportion of subjects with normal body temperature (<=37.2°C) at 4 hours after administration;change in body temperature at 6 hours after administration;average time to normalization of body temperature (<=37.2°C);change in fever comfort score;

Countries

China

Contacts

Public ContactSun, Xin

Department of Pediatrics, Xijing Hospital, the Fourth Military Medical University, Xi'an, China

sunxin6@fmmu.edu.cn+86 135 7253 6262

Outcome results

None listed

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