Dengue, Transaminitis
Conditions
Keywords
Paracetamol
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.
Interventions
DRUGParacetamol
Paracetamol 500 mg x 1 tablets according to patient's body weight
DRUGPlacebo
Placebo 500 mg x 1 tablets according to patient's body weight
Sponsors
Phramongkutklao College of Medicine and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Body temperature | 8 days | Axillary temperature will be recorded every 4 hours until discharge or 8 days after admission, whichever comes first. |
| Number of drug tablet used | 8 days | Number of drug tablet used will be compared, both paracetamol/placebo and tramadol. |
| Duration of fever | 8 days | Duration from the fever onset to the last febrile temperature will be compared. |
| Length of stay | 10 days | Duration from hospital admission to discharge will be compared. |
Countries
Thailand
Outcome results
None listed