Safety of Paracetamol as Antipyretic in Treatment of Dengue Infection in Adults

Not Applicable

Completed

• Conditions: Dengue; Transaminitis
• Interventions: Drug: Placebo; Drug: Paracetamol

• Registration Number: NCT02833584
• Lead Sponsor: Phramongkutklao College of Medicine and Hospital

Brief Summary

The purpose of this study is to determine whether regular dosage of paracetamol causes transaminitis (hepatitis) and evaluate its potency in the treatment of dengue infection.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-14
• Study Start: 2016-09
• Primary Completion: 2017-12
• Study Completion: 2018-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-20
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Patient age >18 years
• 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

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Exclusion Criteria

• Other possible cause of fever other than dengue infection
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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)
Paracetamol	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)

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with abnormal serum transaminase levels on the last day of fever	Day 1-8	Serum alanine transaminase and aspartate transaminase level will be measured at admission, and on every morning afterwards until the subject is discharged. The proportion of subjects with abnormal serum transaminase levels will be compared.
Mean serum transaminase level	Day 1-8	Mean serum transaminase level will be compared.
Mean change in serum transaminase levels	Day 1-8	The change in serum transaminase levels from baseline at admission will be compared.

Secondary Outcome Measures

Name	Time	Method
Number of drug tablet used	8 days	Number of drug tablet used will be compared, both paracetamol/placebo and tramadol.
Body temperature	8 days	Axillary temperature will be recorded every 4 hours until discharge or 8 days after admission, whichever comes first.
Length of stay	10 days	Duration from hospital admission to discharge will be compared.
Duration of fever	8 days	Duration from the fever onset to the last febrile temperature will be compared.

Trial Locations

Locations (3)

Anandamahidol Hospital; 🇹🇭 Lopburi, Thailand

Phramongkutklao College of Medicine and Hospital; 🇹🇭 Bangkok, Thailand

Fort Adisorn Hospital; 🇹🇭 Saraburi, Thailand