Home » Trials » SLCTR/2017/025
Effectiveness of a single dose of oral vs rectal paracetamol in reducing fever in children aged between 2 to 6 years – A Randomized Controlled Single Blind Trial
-
SLCTR Registration Number
SLCTR/2017/025
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Effectiveness of a single dose of oral vs rectal paracetamol in reducing fever in children aged between 2 to 6 years – A Randomized Controlled Single Blind Trial
Public Title of Trial
Effectiveness of a single dose of oral vs rectal paracetamol in reducing fever in children aged between 2 to 6 years – A Randomized Controlled Single Blind Trial
Disease or Health Condition(s) Studied
Fever
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1199-6989
Any other number(s) assigned to the trial and issuing authority
P/103/03/2017 (ERC: Kelaniya)
What is the research question being addressed?
What is the effectiveness of a single dose of oral paracetamol vs rectal paracetamol in reducing fever in children aged between 2 to 6 years?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
The study will be carried out at the paediatric unit of District General Hospital Gampaha.
Consenting patients meeting inclusion/exclusion criteria will be allocated into two study arms using simple randomization.
Arm 1: Single dose of paracetamol syrup 15mg/kg will be given orally. The same preparation (syrup containing 120 mg/5ml of paracetamol) available in the Hospital pharmacy will be used throughout the study.
Arm 2: Single dose of paracetamol suppository 30 mg/kg will be given rectally. The product will be provided by the investigator, and the same preparation will be used throughout the study. Rectal paracetamol is available as 125 mg, 250 mg, 500 mg suppositories, it will be used in suppository form. As partition of the suppository to pieces is difficult, round up method will be used.
The intervention will be administered by trained nurses and the outcomes will be assessed by the principal investigator who will be blind to the interventional status.
Inclusion criteria
Children aged between 2-6 years admitted to the study site
Duration of fever for a maximum of 3 days, irrespective of the cause of fever and irrespective of prior administration of any anti-pyretic or any other medicines
Documented axillary temperature > 100° F at the time of recruitment
Exclusion criteria
Primary outcome(s)
|
1.
Time taken to fever reduction by at least 1°C (rate of temperature reduction) |
[ At 15, 30, 60, 90, 120, 150 and 180 minutes from administration ] |
Secondary outcome(s)
|
1.
Maximum antipyresis following administration of single dose of paracetamol within 3 hours time. |
[ Fro administration to 180 minutes from administration ] |
Target number/sample size
270 (135 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-09-01
Anticipated end date
2017-12-31
Date of first enrollment
2017-08-17
Date of study completion
Recruitment status
Recruiting
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-06-13
Approval number
P/103/03/2017
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
I.B. Nalaka S. Imbulana
Paediatric Registrar
District General Hospital Gampha
0332222261
0715783854
nalakaib@gmail.com
Contact Person for Public Queries
Dr LakKumar Fernando
Consultant Paediatrician
Paediatric Unit,
District General Hospital Gampha
0332222261
0777357565
lakkumar@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
