Safety of Paracetamol as Antipyretic in Treatment of Dengue Infection in Adults
NCT ID: NCT02833584
Last Updated: 2019-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
123 participants
INTERVENTIONAL
2016-09-30
2018-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Paracetamol
Eligible patients will be randomised to receive Paracetamol prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day)
Paracetamol
Paracetamol 500 mg x 1 tablets according to patient's body weight
Placebo
Eligible patients will be randomised to receive Placebo prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day)
Placebo
Placebo 500 mg x 1 tablets according to patient's body weight
Interventions
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Paracetamol
Paracetamol 500 mg x 1 tablets according to patient's body weight
Placebo
Placebo 500 mg x 1 tablets according to patient's body weight
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Dengue infection diagnosed by NS1 antigen, Dengue immunoglobulin M antibody, or polymerase chain reaction
* Admitted to the hospital
* Written informed consent from patient or attending relative able to and willing to give informed consent
Exclusion Criteria
* Pregnancy
* Unable to take medication
* Aminotransferase level above 3 times upper normal limit
* Allergy to paracetamol or tramadol
* Paracetamol indicated for condition other than dengue infection
* Critically ill patient who need ICU or invasive ventilation support
* History of cirrhosis
* Unable to comunicate
18 Years
99 Years
ALL
No
Sponsors
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Phramongkutklao College of Medicine and Hospital
OTHER
Responsible Party
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Principal Investigators
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Dhitiwat Changpradub, MD
Role: STUDY_DIRECTOR
Phramongkutklao College of Medicine and Hospital
Locations
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Phramongkutklao College of Medicine and Hospital
Bangkok, , Thailand
Fort Adisorn Hospital
Changwat Sara Buri, , Thailand
Anandamahidol Hospital
Lopburi, , Thailand
Countries
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References
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Vasikasin V, Rojdumrongrattana T, Chuerboonchai W, Siriwiwattana T, Thongtaeparak W, Niyasom S, Lertliewtrakool N, Jitsiri S, Changpradub D. Effect of standard dose paracetamol versus placebo as antipyretic therapy on liver injury in adult dengue infection: a multicentre randomised controlled trial. Lancet Glob Health. 2019 May;7(5):e664-e670. doi: 10.1016/S2214-109X(19)30032-4.
Other Identifiers
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AMED2016
Identifier Type: -
Identifier Source: org_study_id
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