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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol | Experimental | Eligible patients will be randomised to receive Paracetamol prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day) |
|
| Placebo | Placebo Comparator | Eligible patients will be randomised to receive Placebo prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | Paracetamol 500 mg x 1 tablets according to patient's body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mean serum transaminase level | Mean serum transaminase level will be compared. | Day 1-8 |
| Mean change in serum transaminase levels | The change in serum transaminase levels from baseline at admission will be compared. | Day 1-8 |
| Measure | Description | Time Frame |
|---|---|---|
| Body temperature | Axillary temperature will be recorded every 4 hours until discharge or 8 days after admission, whichever comes first. | 8 days |
| Duration of fever | Duration from the fever onset to the last febrile temperature will be compared. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dhitiwat Changpradub, MD | Phramongkutklao College of Medicine and Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phramongkutklao College of Medicine and Hospital | Bangkok | 10400 | Thailand | |||
| Fort Adisorn Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31000133 | Derived | Vasikasin V, Rojdumrongrattana T, Chuerboonchai W, Siriwiwattana T, Thongtaeparak W, Niyasom S, Lertliewtrakool N, Jitsiri S, Changpradub D. Effect of standard dose paracetamol versus placebo as antipyretic therapy on liver injury in adult dengue infection: a multicentre randomised controlled trial. Lancet Glob Health. 2019 May;7(5):e664-e670. doi: 10.1016/S2214-109X(19)30032-4. |
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| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo | Drug | Placebo 500 mg x 1 tablets according to patient's body weight |
|
| 8 days |
| Length of stay | Duration from hospital admission to discharge will be compared. | 10 days |
| Number of drug tablet used | Number of drug tablet used will be compared, both paracetamol/placebo and tramadol. | 8 days |
| Changwat Sara Buri |
| 18000 |
| Thailand |
| Anandamahidol Hospital | Lopburi | 15000 | Thailand |
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| Aniline Compounds |
| D000588 | Amines |