ClinicalTrials.gg
Not yet recruitingNCT07426744Updated Feb 23, 2026

Antipyretic Therapy With and Without Cold Sponging

An interventional study of Paracetamol and Paracetamol+Cold Sponging in Fever, sponsored by Muhammad Aamir Latif. Not yet recruiting at 1 site in Pakistan. Open to participants aged 6 Months to 60 Months. Per ClinicalTrials.gov, last updated 2026-02-23.

Sponsored by Muhammad Aamir Latif · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
6 Months to 60 Months
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Fever

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03

In context

Fever

438 studies on the registry are indexed under Fever; 55 are open to participants now.

This study's planned enrollment of 210 is above the median of 123 across 271 interventional studies indexed under Fever.

Browse Fever studies →

Lead sponsor

Muhammad Aamir Latif is the lead sponsor of 57 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 60 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 or to paracetamol
  • Presence of dermatological conditions that may aggravate by sponging (eg., eczema, contact dermatitis, psoriasis, skin infection, xerosis)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
210 participants (estimated)

Study arms

  • Experimental
    Paracetamol Group

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

    Drug: Paracetamol

  • 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

Interventions

  • 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.

06

What researchers measure

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.

    Time frame: 60 minutes

Secondary outcomes

  1. Change in heart rate

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

    Time frame: 60 minutes

  2. Change in respiratory rate

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

    Time frame: 60 minutes

07

Study locations

1 site
  • Dr. Ruth KM Pfau Civil Hospital, Karachi, Dow University of Health Sciences
    Karachi, Sindh 74400, Pakistan
    • Roshna Devi · Contactkumarir5694@gmail.com · +923361121599
    • Muhammad Rafique, PCPS · Contactrafique@duhs.edu.pk · +923343522001
    • Roshna Devi · Principal investigator
    • Muhammad Rafique · Principal investigator
08

References and documents

Individual participant data

Plan to share: No — Data can be shared on a reasonable request.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2026; primary completion for Aug 2026, 5 months later.

Of 66 non-industry interventional studies with no phase under Fever, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 5 months is below that.

Counting every sponsor, half of 74 studies reached it within 16 months; a quarter within 6 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2026
First posted
Feb 23, 2026
StartEst.
Mar 1, 2026
Primary completionEst.
Aug 31, 2026
CompletionEst.
Aug 31, 2026
Last update
Feb 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07426744
Lead sponsor
Muhammad Aamir Latif
Responsible party
Muhammad Aamir Latif (Research Consultant, RESnTEC, Institute of Research) — Sponsor-investigator
First posted
Feb 23, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Feb 23, 2026

Study contacts

Roshna Devi
Contact
kumarir5694@gmail.com
+923361121599
Muhammad Rafique, FCPS
Contact
rafique@duhs.edu.pk
+923343522001
Roshna Devi
principal investigator · Dr. Ruth KM Pfau Civil Hospital, Karachi, Dow University of Health Sciences, Karachi
Muhammad Rafique, FCPS
study director · Dr. Ruth KM Pfau Civil Hospital, Karachi, Dow University of Health Sciences, Karachi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Acetaminophen

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