Antipyretic Therapy With and Without Cold Sponging

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Fever
• Intervention / Treatment: Drug: Paracetamol; Combination product: Paracetamol+Cold Sponging

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.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roshna Devi; Phone Number: +923361121599; Email: kumarir5694@gmail.com
• Study Contact Backup: Name: Muhammad Rafique, FCPS; Phone Number: +923343522001; Email: rafique@duhs.edu.pk

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74400
      • Dr. Ruth KM Pfau Civil Hospital, Karachi, Dow University of Health Sciences
      • Contact: Roshna Devi; Phone Number: +923361121599; Email: kumarir5694@gmail.com
      • Contact: Muhammad Rafique, PCPS; Phone Number: +923343522001; Email: rafique@duhs.edu.pk
      • Principal Investigator: Roshna Devi
      • Principal Investigator: Muhammad Rafique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paracetamol Group; Children will receive paracetamol alone, as a single dose of paracetamol syrup (15 mg/kg) orally.	Drug: Paracetamol; Children will receive paracetamol alone, as a single dose of paracetamol syrup (15 mg/kg) orally.
Experimental: Cold sponging Group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fever reduction	Achievement of a temperature <38°C within 60 minutes will be considered as the reduction in fever and effectiveness of the treatment.	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate	The change in the heart rate will be compared between the two groups.	60 minutes
Change in respiratory rate	The change in the respiratory rate will be compared between the two groups.	60 minutes

Collaborators and Investigators

• Sponsor: Muhammad Aamir Latif
• Investigators: Principal Investigator: Roshna Devi, Dr. Ruth KM Pfau Civil Hospital, Karachi, Dow University of Health Sciences, Karachi; Study Director: Muhammad Rafique, FCPS, Dr. Ruth KM Pfau Civil Hospital, Karachi, Dow University of Health Sciences, Karachi

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fever; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Acetaminophen
• Other Study ID Numbers: Dr-Roshna-Karachi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be shared on a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No