Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000083392
Ethics application status
Approved
Date submitted
12/02/2008
Date registered
14/02/2008
Date last updated
14/02/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tepid sponging and dipyrone versus dipyrone alone for reduction of body temperature in febrile children
Scientific title
Tepid sponging and dipyrone versus dipyrone alone for reduction of body temperature in febrile children - a clinical trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment of fever 2816 0
Fever in children 2817 0
Condition category
Condition code
Other 2954 2954 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dipyrone (20 mg/Kg) oral syrup by mouth at the beginning of the study and tepid sponging during 15 minutes
Intervention code [1] 2553 0
Treatment: Other
Comparator / control treatment
Dipyrone oral syrup at the beginning of the study.
Control group
Active

Outcomes
Primary outcome [1] 3833 0
Axillary temperatures was the primary outcome and it was measured with a mercury-in-glass thermometer
Timepoint [1] 3833 0
Body temperature measured with 15, 30, 60, 90 and 120 minutes after the beginning of the study.
Secondary outcome [1] 6461 0
Crying
Timepoint [1] 6461 0
15 minutes

Eligibility
Key inclusion criteria
Children attended between 5:00 h p.m and 7:00 h p.m. and aged from 6 to 60 months with an axillary temperature of between 38.5 C and 40 C and a clinical diagnosis consistent with upper respiratory tract infections (URTI). Able to stay in the emergency ward for at least two hours.
Minimum age
6 Months
Maximum age
60 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Requiring admission, urgent investigation or emergency treatment and those who had received antipyretic, steroids or non-steroidal anti-inflammatory drugs (NSAIDs) during the previous six hours were excluded, as where children with known liver or renal diseases, gastrointestinal bleeding, known allergy to dipyrone, congenital or acquired immunodeficiency or malignancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children were assigned randomly by drawing a numbered envelope to receive oral dipyrone and tepid sponging (sponging group) or dipyrone only (control group).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Epi-info software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 787 0
Brazil
State/province [1] 787 0
Pernambuco

Funding & Sponsors
Funding source category [1] 3083 0
Government body
Name [1] 3083 0
Conselho Nacional de Desenvolvimento Cient?fico e Tecnologico (CNPq)
Country [1] 3083 0
Brazil
Primary sponsor type
Government body
Name
Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
Address
Quadra B - Lote A08 - Brasília - Distrito Federal (DF)
Country
Brazil
Secondary sponsor category [1] 2773 0
Hospital
Name [1] 2773 0
Instituto Materno Infantil Prof Fernando Figueira
Address [1] 2773 0
Rua dos Coelhos, 300 - Boa Vista
Recife - PE
Country [1] 2773 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5027 0
Instituto Materno Infantil Prof Fernando Figueira (IMIP)
Ethics committee address [1] 5027 0
Rua dos Coelhos, 300 - Boa Vista
Recife - PE
Ethics committee country [1] 5027 0
Brazil
Date submitted for ethics approval [1] 5027 0
Approval date [1] 5027 0
02/11/2006
Ethics approval number [1] 5027 0
639.06

Summary
Brief summary
The role of tepid sponging to promote fever control in children is controversial. We did not find studies reporting the effectiveness of tepid sponging in addition to dipyrone. The aim of this study is to compare the effects of tepid sponging plus dipyrone with dipyrone alone in reducing fever.
This randomized clinical trial will take place at Instituto Materno-Infantil Professor Fernando Figueira, Teaching Hospital, Recife, Pernambuco.
Children from 6 months to 5 years old with axillary temperature > 38 C in the emergency ward between January and July 2006 are eligible. One hundred-twenty children will be randomly assigned to receive oral dipyrone (20 mg/Kg) or oral dipyrone and tepid sponging during 15’. The primary outcome is the mean temperature reduction after 15, 30, 60, 90 and 120 minutes. Secondary outcomes are crying and irritability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28366 0
Address 28366 0
Country 28366 0
Phone 28366 0
Fax 28366 0
Email 28366 0
Contact person for public queries
Name 11523 0
João Guilherme Bezerra Alves
Address 11523 0
Rua dos Coelhos, 300 - Boa Vista
Recife - PE
Country 11523 0
Brazil
Phone 11523 0
(81) 99746351
Fax 11523 0
(81) 21224154
Email 11523 0
joaoguilherme@imip.org.br
Contact person for scientific queries
Name 2451 0
João Guilherme Bezerra Alves
Address 2451 0
Rua dos Coelhos, 300 - Boa Vista
Recife - PE
Country 2451 0
Brazil
Phone 2451 0
(81) 99746351
Fax 2451 0
(81) 21224154
Email 2451 0
joaoguilherme@imip.org.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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