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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2017/025
Enrollment
Unknown
Registered
2017-08-17
Start date
2017-09-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Fever

Interventions

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

Sponsors

District General Hospital Gampha, Sri Lanka
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged between 2-6 years admitted to the study site 2. 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 3. Documented axillary temperature > 100° F at the time of recruitment

Exclusion criteria

Exclusion criteria: 1. Children with known allergy to paracetamol 2. Conditions that preclude oral (example: vomiting) rectal (example: diarrhoea) administration of medicines 3. Children with reduced level of consciousness 4. Children who had possible overdose of paracetamol 5. Children who had any anti pyretic within 8 hours of admission

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Maximum antipyresis following administration of single dose of paracetamol within 3 hours time. [Fro administration to 180 minutes from administration]

Countries

Sri Lanka

Contacts

Public ContactI.B. Nalaka S. Imbulana

Paediatric Registrar

nalakaib@gmail.com0332222261

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026