Antipyretic Therapy With and Without Cold Sponging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Paracetamol, Paracetamol+Cold Sponging.
- Who it may be relevant to
- Registry conditions: Fever. Basic parameters: 6 months — 60 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Antipyretic Therapy With and Without Cold Sponging: A Comparative Study in Febrile Children.
Overview
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
- Drug Paracetamol
Children will receive paracetamol alone, as a single dose of paracetamol syrup (15 mg/kg) orally. - Combination product Paracetamol+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.
Primary outcome measures
- Fever reduction [Time frame: 60 minutes]
Secondary outcome measures (2)
- Change in heart rate [Time frame: 60 minutes]
- Change in respiratory rate [Time frame: 60 minutes]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Dr. Ruth KM Pfau Civil Hospital, Karachi, Dow University of Health Sciences — Karachi
Identifiers
NCT: NCT07426744 · Dr-Roshna-Karachi