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

Dengue Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02833584
• Other study ID #: AMED2016
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: January 2018

Study information

• Verified date: April 2019
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Dengue
• Transaminitis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Thailand	Phramongkutklao College of Medicine and Hospital	Bangkok
Thailand	Anandamahidol Hospital	Lopburi
Thailand	Fort Adisorn Hospital	Saraburi

Sponsors (1)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with abnormal serum transaminase levels on the last day of fever	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.	Day 1-8
Primary	Mean serum transaminase level	Mean serum transaminase level will be compared.	Day 1-8
Primary	Mean change in serum transaminase levels	The change in serum transaminase levels from baseline at admission will be compared.	Day 1-8
Secondary	Body temperature	Axillary temperature will be recorded every 4 hours until discharge or 8 days after admission, whichever comes first.	8 days
Secondary	Duration of fever	Duration from the fever onset to the last febrile temperature will be compared.	8 days
Secondary	Length of stay	Duration from hospital admission to discharge will be compared.	10 days
Secondary	Number of drug tablet used	Number of drug tablet used will be compared, both paracetamol/placebo and tramadol.	8 days