Fever
Conditions
Brief summary
This study aims to fill the gaps regarding the effectiveness of paracetamol alone with paracetamol combined with cold sponging in febrile children.
Detailed description
Given the conflicting findings in existing literature, the role of cold sponging in fever management remains uncertain. Some studies suggest a transient advantage in early temperature reduction, while others highlight limited long-term benefit and increased discomfort. Therefore, this study seeks to determine whether cold sponging offers meaningful additional benefit or merely adds distress without enhancing the efficacy of paracetamol. The findings would generate evidence-based guidance for using cold sponging in febrile children.
Interventions
DRUGParacetamol
Children will receive paracetamol alone, as a single dose of paracetamol syrup (15 mg/kg) orally.
COMBINATION_PRODUCTParacetamol+Cold Sponging
Children 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.
Sponsors
Muhammad Aamir Latif
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 60 Months
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fever reduction | 60 minutes | Achievement of a temperature \<38°C within 60 minutes will be considered as the reduction in fever and effectiveness of the treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in heart rate | 60 minutes | The change in the heart rate will be compared between the two groups. |
| Change in respiratory rate | 60 minutes | The change in the respiratory rate will be compared between the two groups. |
Countries
Pakistan
Contacts
CONTACTRoshna Devi
CONTACTMuhammad Rafique, FCPS
PRINCIPAL_INVESTIGATORRoshna Devi
Dr. Ruth KM Pfau Civil Hospital, Karachi, Dow University of Health Sciences, Karachi
STUDY_DIRECTORMuhammad Rafique, FCPS
Dr. Ruth KM Pfau Civil Hospital, Karachi, Dow University of Health Sciences, Karachi
Outcome results
None listed