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NCT Number: NCT07426744

Antipyretic Therapy With and Without Cold Sponging

This study aims to fill the gaps regarding the effectiveness of paracetamol alone with paracetamol combined with cold sponging in febrile children.

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Key information

Conditions

Fever Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Ruth KM Pfau Civil Hospital, Karachi, Dow University of Health Sciences

Karachi, Sindh, 74400, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Paracetamol

Drug

Children will receive paracetamol alone, as a single dose of paracetamol syrup (15 mg/kg) orally.

Paracetamol+Cold Sponging

Combination Product

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 outcomes

  1. Fever reduction

    Time frame: 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 outcomes

  1. Change in heart rate

    Time frame: 60 minutes

    The change in the heart rate will be compared between the two groups.

  2. Change in respiratory rate

    Time frame: 60 minutes

    The change in the respiratory rate will be compared between the two groups.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

Antipyretic Therapy With and Without Cold Sponging: A Comparative Study in Febrile Children.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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