Safety of Paracetamol as Antipyretic in Treatment of Dengue Infection in Adults
ClinicalTrials.gov ID
NCT02833584
Lead Sponsor
Phramongkutklao College of Medicine and HospitalOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
123Actual
Last Update Posted
Apr 23, 2019Actual
Start Date
Sep 2016
Primary Completion Date
Dec 2017Actual
Completion Date
Jan 2018Actual
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.
Dengue
Transaminitis
Paracetamol
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
No central contacts
There are no central contacts for this study.
Phramongkutklao College of Medicine and Hospital
Bangkok, 10400, Thailand
Fort Adisorn Hospital
Changwat Sara Buri, 18000, Thailand
Anandamahidol Hospital
Lopburi, 15000, Thailand
Lead Sponsor
Phramongkutklao College of Medicine and HospitalOTHER