Comparison of effects of paracetamol, ibuprofen and their combination in pediatric patients with fever

Randomized Comparative Trial of efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination in treatment of febrile children

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000330

Enrollment

Registered

2009-06-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Fever in children

Interventions

Intervention1: paracetamol: 15 mg/kg, single dose orally Control Intervention1: Ibuprofen: 10 mg/kg, single dose, orally Control Intervention2: paracetamol+ibuprofen combination: 15 mg/kg paracetamol

Eligibility

Inclusion criteria

Inclusion criteria: Hospitalized and children attending Outpatient department of V.S. general hospital, Ahmedabad. Between 6 months to 12 years of age of either sex, Temperature of ≥ 38° C, Free and informed written consent from father, mother or legal guardian obtained

Exclusion criteria

Exclusion criteria: Paracetamol, ibuprofen, combination of paracetamol-ibuprofen or any other anti pyretic drug given in the previous six hours, Allergy/hypersensitivity to either paracetamol or ibuprofen, Severe or life threatening infections, meningitis, severely ill patients suffering from circulatory collapse, , Cellulites or other spreading skin infection, suspected chicken pox, Known to be immuno-suppressed, Acute jaundice, Symptoms of active GI bleeding, known blood dyscrasias or coagulopathy, Chronic renal, liver or cardiac failure, Dehydration suspected clinically, Medicated with warfarin, heparin or anti-hypertensives, Asthma defined as a need for regular preventive medication, Body weight below 7 kg.

Design outcomes

Primary

Measure	Time frame
Decrease in the temperature in comparison with the baseline temperature, at the end of 4 hours after the drug administrationTimepoint: 4 hour	—

Secondary

Measure	Time frame
Decrease in the temperature at first, second and third hour after the drug given; that is the rate of fall of temperature with time.-- Percent reduction of temperature.-- Proportion of afebrile children at 1, 2, 3, and 4 hours. -- Assessment of safety of the drug. Any adverse drug reactions during the 4 hour period after the drug given. -- Assessment of improvement of general condition; categorical improvement in activity, alertness, mood, comfort, appetite and fluid intake. Timepoint: 1 hour, 2 hour, 3 hour and 4 hour	—

Measure

Time frame

Decrease in the temperature at first, second and third hour after the drug given; that is the rate of fall of temperature with time.-- Percent reduction of temperature.-- Proportion of afebrile children at 1, 2, 3, and 4 hours. -- Assessment of safety of the drug. Any adverse drug reactions during the 4 hour period after the drug given. -- Assessment of improvement of general condition; categorical improvement in activity, alertness, mood, comfort, appetite and fluid intake. Timepoint: 1 hour, 2 hour, 3 hour and 4 hour

—

Countries

India

Contacts

Public ContactDr Falgun Indravadan Vyas

V S General Hospital

drvarsha4@rediffmail.com09909429944

Outcome results

None listed

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