Health Condition 1: R509- Fever, unspecified
Conditions
Interventions
Intervention1: Paracetamol solution for Injection: 450 mg per 3 ml
Duration of study is 7 days
Frequency first day of the duration
Control Intervention1: NA: NA
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Having fever oral temperature between 101 to 104 F both inclusive of recent onset more than 3 days and expected to be hospitalized more than 24 hrs 2 Willing to comply with study requirements including periodic measurements or examinations laboratory investigations and avoiding any intramuscular administration during the entire study duration of 7 days as documented by provision of written Informed Consent prior to participation in the study
Exclusion criteria
Exclusion criteria: 1 Fever suspected to be due to neurological infection or any cancer 2 Patient receiving any IM injection for the co morbid condition and where the IM injection are expected to continue 3 High grade fever more than 104 F or suspected septicemia 4 Hypotension inferred from systolic blood pressure more than 90 mmHg 5 Admission in intensive care unit or intensive cardiac care unit 6 Severe kidney creatinine more than 2 mg per dl or liver disease SGOT and SGPT more than 3 times ULN and based on discretion of the investigator 7 Patients with serum CPK levels more than 5 times the ULN for that gender
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Proportion of completed patients achieving target oral temperatureTimepoint: 180 ± 15 minutes after study drug administration or before | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Mean reduction in oral temperature at each time point compared to baseline 2 Proportion of patients administered rescue drug before 180 minutes from administration of study drug Timepoint: Proportion of patients administered rescue drug before 180 minutes | — |
Countries
India
Contacts
Public ContactPratik Shah
Troikaa Pharmaceuticals Limited
Outcome results
None listed