Efficacy of oral mefenamic acid as an antipyretic in comparison to oral paracetamol in pediatric patients with acute febrile illness

Not Applicable

Completed

• Conditions: Health Condition 1: R509- Fever, unspecified

• Registration Number: CTRI/2021/12/038628
• Lead Sponsor: CENTRAL INSTITUTIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-11-14
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 78

Inclusion Criteria

1. All children with acute onset fever aged between 2-15yrs of age

2. Hospitalized patients, all types of febrile illness.

3. child should be able to take oral medications

4. Even if the child received any medications related to this study drugs, we are going to include them in this study

Exclusion Criteria

1. patients with acute febrile illness presenting in shock

2. patient having acute kidney injury

3. patient having clinical jaundice

4. patient with suspected or diagnosed with meningitis at the time of admission

5. patient with acute or old stroke

6. patient with a known history of hemolysis

7. patient who has already been diagnosed with malignancy

8. patient having severe gastritis/repeated vomiting/diarrhea at the time of admission

9. patient with known hypersensitivity to any of the study drugs

10. a patient who has received injectable antibiotics within the last 48hours before admission from outside hospital.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.proportion of the patients achieving axillary temperature of 99F or less at the end of two hours after intervention.Timepoint: 2 hours after intervention

Secondary Outcome Measures

Name	Time	Method
1.the number of adverse events observed in the study groups <br/ ><br>2. time required for the initial response of each drug <br/ ><br>3.the average temperature during the study period of 12hours in each group <br/ ><br>4.the average fever free interval in each group during the study period <br/ ><br>5.the average frequency of drug administration in each group <br/ ><br>6. average total dose in mg/kg required in the 1st 12hour <br/ ><br>7. tolerability of each drug using modified treatment tolerability evaluation score and other side effects as mentioned below will be monitored for 48hours <br/ ><br>a. gastroinstenial:nausea, vomiting, loose motions, GI bleeding, abdominal pain. <br/ ><br>b. Hepatic:jaundice, alteration of LFT (symptomatic or asymptomatic increase in AST/ALT) <br/ ><br>c.renal side effects:hematuria, AKI <br/ ><br>D.hematological: hemolysis <br/ ><br>e. CNS: convulsions, stroke <br/ ><br>f. othersTimepoint: 12hours