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This study aims to fill the gaps regarding the effectiveness of paracetamol alone with paracetamol combined with cold sponging in febrile children.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol Group | Experimental | Children will receive paracetamol alone, as a single dose of paracetamol syrup (15 mg/kg) orally. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | Children will receive paracetamol alone, as a single dose of paracetamol syrup (15 mg/kg) orally. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roshna Devi | Contact | +923361121599 | kumarir5694@gmail.com | |
| Muhammad Rafique, FCPS | Contact | +923343522001 | rafique@duhs.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Ruth KM Pfau Civil Hospital, Karachi, Dow University of Health Sciences | Karachi | Sindh | 74400 | Pakistan |
Data can be shared on a reasonable request.
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 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. |
|
| 60 minutes |
| Aniline Compounds |
| D000588 | Amines |