FeverNCT07426744
Antipyretic Therapy With and Without Cold Sponging
A study testing Paracetamol and Paracetamol+Cold Sponging in people with Fever, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
This study aims to fill the gaps regarding the effectiveness of paracetamol alone with paracetamol combined with cold sponging in febrile children. Read more about this study
- Who is it for?
- Ages 6 to 60 months
- Conditions the study is for
- Fever
- What is being tested?
- Paracetamol and Paracetamol+Cold Sponging
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Dr. Ruth KM Pfau Civil Hospital, Karachi, Dow University of Health Sciences
Karachi, Sindh, 74400
Roshna Devi, +923361121599, kumarir5694@gmail.com
Muhammad Rafique, PCPS, +923343522001, rafique@duhs.edu.pk
About this study
Official title: 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.
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.
- Conditions
- Fever
- Being tested
- Paracetamol, Paracetamol+Cold Sponging
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Children will receive paracetamol alone, as a single dose of paracetamol syrup (15 mg/kg) orally.
Paracetamol+Cold SpongingCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol Group | Experimental | Children will receive paracetamol alone, as a single dose of paracetamol syrup (15 mg/kg) orally. Receives: 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. Receives: Combination Product: Paracetamol+Cold Sponging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fever reduction
Achievement of a temperature <38°C within 60 minutes will be considered as the reduction in fever and effectiveness of the treatment.
Measured: 60 minutes
Secondary outcomes (2)
Change in heart rate
The change in the heart rate will be compared between the two groups.
Measured: 60 minutes
Change in respiratory rate
The change in the respiratory rate will be compared between the two groups.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Roshna Devi, Principal investigator, Dr. Ruth KM Pfau Civil Hospital, Karachi, Dow University of Health Sciences, KarachiMuhammad Rafique, FCPS, Study director, Dr. Ruth KM Pfau Civil Hospital, Karachi, Dow University of Health Sciences, Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426744
- Sponsor's protocol ID
- Dr-Roshna-Karachi
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antipyretic Therapy With and Without Cold Sponging: A Comparative Study in Febrile Children.
- ClinicalTrials.gov ID
- NCT07426744
- Acronym / sponsor ID
- Dr-Roshna-Karachi
- Conditions
- Fever
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol Group | Experimental | Drug: ParacetamolChildren will receive paracetamol alone, as a single dose of paracetamol syrup (15 mg/kg) orally. |
| Cold sponging Group | Experimental | Combination Product: Paracetamol+Cold SpongingChildren 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. |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolChildren will receive paracetamol alone, as a single dose of paracetamol syrup (15 mg/kg) orally. | Drug | Paracetamol Group |
| Paracetamol+Cold SpongingChildren 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 | Cold sponging Group |
Primary outcome
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.
2 secondary outcomes
Change in heart rate
Time frame: 60 minutes
Change in respiratory rate
Time frame: 60 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol and Paracetamol+Cold Sponging in people with Fever, run by Muhammad Aamir Latif at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roshna Devi (+923361121599, kumarir5694@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fever reduction (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.