| CTRI Number |
CTRI/2025/07/091929 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Two Common Medicines for Fever in Children: A Study of Paracetamol with high dose and Ibuprofen with regular dose |
|
Scientific Title of Study
|
A randomised controlled trial comparing high-dose paracetamol and oral ibuprofen for fever management in children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KANCHANKUMAR BHAGYAWANT |
| Designation |
CONSULTANT PEDIATRICIAN |
| Affiliation |
RUBY HALL CLINIC |
| Address |
RUBY HALL CLINIC
40 SASSOON ROAD
PUNE
FLAT NO 604
KUMAR PLATINUM
SYNAGOGUE STREET
PUNE
Pune
MAHARASHTRA
411001
India |
| Phone |
9860937972 |
| Fax |
|
| Email |
drkanchankumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JEEBAN KUMAR JENA |
| Designation |
DNB STUDENT, PEDITRICS |
| Affiliation |
RUBY HALL CLINIC |
| Address |
RUBY HALL CLINIC
40 SASSOON ROAD
PUNE
Pune
MAHARASHTRA
411001
India |
| Phone |
8763180697 |
| Fax |
|
| Email |
mail2jeeban@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KANCHANKUMAR BHAGYAWANT |
| Designation |
CONSULTANT PEDIATRICIAN |
| Affiliation |
RUBY HALL CLINIC |
| Address |
RUBY HALL CLINIC
40 SASSOON ROAD
PUNE
FLAT NO 604
KUMAR PLATINUM
SYNAGOGUE STREET
PUNE
Pune
MAHARASHTRA
411001
India |
| Phone |
9860937972 |
| Fax |
|
| Email |
drkanchankumar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR KANCHANKUMAR BHAGYAWANT |
| Address |
RUBY HALL CLINIC
40, SASSOON ROAD
PUNE 411001 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR JEEBAN KUMAR JENA |
RUBY HALL CLINIC
PUNE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrKanchankumar Bhagyawant |
RUBY HALL CLINIC |
PEDIATRIC WARD, PEDIATRIC DEPARTMENT, RUBY HALL CLINIC, 40 SASSOON ROAD
PUNE 411001
Pune
MAHARASHTRA |
9860937972
drkanchankumar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE BIOMEDICAL AND HEALTH RESEARCH POONA MEDICAL RESEARCH FOUNDATION |
Approved |
| POONA MEDICAL RESEARCH FOUNDATION INSTITUTIONA ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B999||Unspecified infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IBUPROFEN |
IF FEVER, AFTER RECORDING TEMPERATURE, ORAL IBUPROFEN WITH DOSE 6 MG/KG/DOSE IS GIVEN ORALLY. THE DOSE WILL BE REPEATED AFTER 6 HOURS IF FEVER. DURATION OF TREATMENT TILL THE PATIENT RECOVERS FROM THE ILLNESS. |
| Intervention |
PARACETAMOL |
IF FEVER, AFTER RECORDING TEMPERATURE , HIGH DOSE PARACETAMOL (20MG/KG/DOSE) IS GIVEN ORALLY. THE DOSE WILL BE REPEATED AFTER 6 HOURS IF FEVER. DURATION OF TREATMENT TILL THE PATIENT RECOVERS FROM THE ILLNESS. |
| Comparator Agent |
PARACETAMOL |
IF FEVER, AFTER RECORDING TEMPERATURE , STANDARD DOSE OF PARACETAMOL (15MG/KG/DOSE) IS GIVEN ORALLY. THE DOSE WILL BE REPEATED AFTER 6 HOURS IF FEVER. DURATION OF TREATMENT TILL THE PATIENT RECOVERS FROM THE ILLNESS. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients with fever (axillary temperature of more than 100 F) admitted to pediatric ward in Ruby Hall Clinic and willing to participate in study. |
|
| ExclusionCriteria |
| Details |
1.Those patients who have received either of the drug in previous 6 hours.
2.Received antibiotics prior to admission.
3.Those receiving anti-coagulants warfarin, heparin etc.
4.Those patients having localized inflammatory pain.
5.Known case of asthma.
6.Known case of allergy to either drug.
7.Chronic cardiac or hepatic or renal failure requiring ICU care.
8.Any clinical adverse event or serious illness.
9.Those patients not willing to participate in study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. time taken to reduce fever by either of the drug
2. The decrease in fever associated discomfort following administration of either drug. |
AT BASELINE, 4 DAYS AND 8 DAYS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine any immediate adverse effects following drug administration. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a double-blinded randomized controlled trial designed to compare the efficacy and safety of high-dose paracetamol versus oral ibuprofen in managing fever among children aged 6 to 18 years. Conducted over 24 months at Ruby Hall Clinic, it will enroll 69 participants and evaluate how quickly each drug reduces fever and associated discomfort, along with any immediate adverse effects. Temperature will be monitored every 30 minutes, and pain scores assessed using age-appropriate tools.Children meeting inclusion criteria will receive weight-based doses of either drug every 6 hours, with both caregivers and nurses blinded to the treatment groups. The study excludes children with prior drug use, allergies, or severe illness. Ethical approval and informed consent are mandatory, with no use of placebo or off-label drugs, and no additional cost to participants. The central hypothesis is that high-dose paracetamol may be more effective than ibuprofen in reducing fever in children. |