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

Efficacy of oral mefenamic acid as an antipyretic in comparison to oral paracetamol in pediatric patients with acute febrile illness: An open label randomized controlled trial. ? - open label randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038628
Enrollment
76
Registered
2021-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R509- Fever, unspecified

Interventions

Control Intervention1: paracetamol: (10-15mg/kg/dose),orally, At a interval of 6hours,duration of study-12hours Control Intervention2: mefenamic acid: (5-8mg/kg/dose),orally, duration of next dose-4ho

Sponsors

CENTRAL INSTITUTION
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

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

Countries

India

Contacts

Public ContactShirisha k

pediatrics

tusharjagzape@aiimsraipur.edu.in9421783796

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026