The Antipyretic Efficacy of Oral and Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever.

Study Overview
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Brief Summary
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A randomized clinical trial to check the antipyretic efficacy of oral and intravenous paracetamol and intramuscular diclofenac sodium in patients presenting with fever to emergency department.

Official Title
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A Randomized Controlled Clinical Trial on the Antipyretic Efficacy of Oral Paracetamol, Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever to Emergency Department

Conditions
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Fever, Reduction in Temperature

Intervention / Treatment
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* Drug: Oral paracetamol
* Drug: Intravenous paracetamol
* Drug: Intramuscular diclofenac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between the age of 14-75 years with an oral temperature of more than 38.5 C Exclusion Criteria: History of allergy to any of the drugs in the study Had taken antipyretics within 8 hours Renal, hepatic or haematological disorders bronchial asthma, peptic ulcer disease, vomiting Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral paracetamol<br>patients in this arm will receive 1000mg of oral paracetamol | Drug: Oral paracetamol<br>* after giving medicine temperature is checked every 30 minutes for 2 hours<br>|
| Active Comparator: Intravenous paracetamol<br>patients in this arm will receive 1000 mg of intravenous paracetamol | Drug: Intravenous paracetamol<br>* after giving medicine temperature is checked every 30 minutes for 2 hours<br>|
| Active Comparator: Intramuscular Diclofenac<br>patients in this arm will receive 75 mg of intramuscular diclofenac sodium | Drug: Intramuscular diclofenac<br>* after giving medicine temperature is checked every 30 minutes for 2 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in temperature in every thirty minutes till 120 minutes after receiving antipyretics | Once the patients fulfill the inclusion criteria, they are randomly assigned to receive one of the three medications in the study ( oral paracetamol, intravenous paracetamol or intramuscular diclofenac). Baseline temperature is recorded using a standard thermometer. Then reduction in temperature is recorded every 30 minutes for 2 hours. | Reduction in temperature is checked every 30 minutes for a maximum of 120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antipyretics, oral paracetamol, intravenous paracetamol, intramuscular diclofenac, emergency department