Antipyretic Therapy With and Without Cold Sponging

NCT07426744 | Not Yet Recruiting

• 1 other identifier: Dr-Roshna-Karachi
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fever

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in heart rate

  60 minutes

• Change in respiratory rate

  60 minutes

Study Arms (2)

Paracetamol Group

EXPERIMENTAL

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

Drug: Paracetamol

Cold sponging Group

EXPERIMENTAL

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

Interventions

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.

Cold sponging Group

Paracetamol DRUG

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

Paracetamol Group

Eligibility Criteria

• Age: 6 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

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

Karachi, Sindh, 74400, Pakistan

Location

MeSH Terms

Conditions

Fever

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Roshna Devi

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

  PRINCIPAL INVESTIGATOR

• Muhammad Rafique, FCPS

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

  STUDY DIRECTOR

Central Study Contacts

Roshna Devi

CONTACT

+923361121599; kumarir5694@gmail.com

Muhammad Rafique, FCPS

CONTACT

+923343522001; rafique@duhs.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)