About this trial
This study aims to fill the gaps regarding the effectiveness of paracetamol alone with paracetamol combined with cold sponging in febrile children.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children of either gender
Aged 6 to 60 months.
Presenting with a fever (an axillary or oral temperature >38.0°C)
No use of paracetamol or other antipyretics within the past 6 hours. 4. Parental/guardian giving informed written consent.
Disqualifiers
Children with chronic systematic conditions (e.g., congenital heart defects, renal or respiratory diseases)
History of febrile seizures or other seizure disorders
Known hypersensitivity or contraindication to paracetamol
Presence of dermatological conditions that may aggravate by sponging (eg., eczema, contact dermatitis, psoriasis, skin infection, xerosis)
Trial design
Parallel
Treatments tested in this trial
Paracetamol
DrugChildren will receive paracetamol alone, as a single dose of paracetamol syrup (15 mg/kg) orally.
Paracetamol+Cold Sponging
Combination productChildren will receive paracetamol as a single dose of paracetamol syrup (15 mg/kg) orally, and cold sponging will be performed immediately following paracetamol administration for 15 minutes, using room-temperature water (approximately 25°C) to sponge the forehead, arms, and legs.
Treatment groups
Trial outcomes
Primary outcomes
Fever reduction
Achievement of a temperature \<38°C within 60 minutes will be considered as the reduction in fever and effectiveness of the treatment.
Secondary outcomes
Change in heart rate
The change in the heart rate will be compared between the two groups.
Change in respiratory rate
The change in the respiratory rate will be compared between the two groups.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Muhammad Aamir Latif
Lead sponsor
RESnTEC, Institute of Research
Sponsor institution
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