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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 -

SLCTR Registration Number

SLCTR/2017/025


Date of Registration

17 Aug 2017

The date of last modification

Sep 14, 2017


View original TRDS



Application Summary


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 of Health Condition(s) Studied

Fever


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1199-6989


Any other number(s) assigned to the trial and issuing authority

P/103/03/2017 (ERC: Kelaniya)


Trial Details


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


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

  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

  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


Primary outcome(s)

Time taken to fever reduction by at least 1°C (rate of temperature reduction)


Primary outcome(s) - Time of assessment(s)

At 15, 30, 60, 90, 120, 150 and 180 minutes from administration


Secondary outcome

Maximum antipyresis following administration of single dose of paracetamol within 3 hours time.


Secondary outcome(s) - Time of assessment(s)

Maximum antipyresis following administration of single dose of paracetamol within 3 hours time.



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


Recruitment status

Recruiting


State of ethics review approval

Approved by the Ethical Review Committee of Faculty of Medicine University of Kelaniya, Ragama on 13th june 2017 (Ref. P/103/03/2017)


Funding source

None (investigator funded)



Contact & Sponsor Information


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


Primary study sponsor/organization

District General Hospital Gampha, Sri Lanka


0332222261
0332222179

Secondary study sponsor (If any)

None