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

Phramongkutklao College of Medicine and Hospital

Status: Completed

Conditions: Transaminitis; Dengue

Treatments: Drug: Placebo; Drug: Paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT02833584

AMED2016

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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123 participants in 2 patient groups, including a placebo group

Paracetamol

Experimental group

Description:

Eligible patients will be randomised to receive Paracetamol prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day)

Treatment:

Drug: Paracetamol

Placebo

Placebo Comparator group

Description:

Eligible patients will be randomised to receive Placebo prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day)

Treatment:

Drug: Placebo