A New Formulation of Intravenous Paracetamol for Fever Management

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The efficacy of intravenous paracetamol has never been compared with other drugs for the management of fever due to infections. Available data come from clinical studies conducted in healthy volunteers subject to experimental endotoxemia. The present study compares the efficacy of the new ΑPOTEL Μax® formulation versus placebo for the management of fever of infectious origin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
• Collaborators: Attikon Hospital; General Hospital of Chalkida; General Hospital Of Thessaloniki Ippokratio; Thriasion Elefsis General Hospital; University Hospital of Crete; University Hospital of Patras
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

1. Written informed consent by the patient

2. Patient of either gender

3. Age equal to or greater than 18 years old

4. Fever onset less than 24 hours

5. Body temperature greater than or equal to 38.50C.

6. Infection of the upper respiratory tract or of the lower respiratory tract or acute pyelonephritis or infection of the skin and soft tissues that can explain fever onset.

Exclusion Criteria:

1. Age below 18 years old

2. Denial for written consent

3. Intake of paracetamol for any reason either orally or intravenously or intramuscularly the last 12 hours

4. Intake of any non-steroidal anti-inflammatory drug the last 8 hours

5. Intake of any steroidal anti-inflammatory drug the last 12 hours

6. History of liver cirrhosis

7. Serum creatinine greater than 3 mg/dl

8. Aspartate aminotransferase more than 3 times greater than the upper normal limit for the hospital lab

9. Known allergy to non-steroidal anti-inflammatory drugs or to paracetamol

10. Pregnancy or lactation

11. Active bleeding of the upper or the lower gastrointestinal tract

12. Thrombocytopenia defined as any absolute platelet count below 50000/mm3.