Clinical trial · Interventional
Paracetamol as Antipyretic and Analgesic Medication
An Open-label Non-randomized Phase IV Trial of the Clinical Efficacy of Intravenously Administered 1000mg Paracetamol as Antipyretic and Analgesic Medication
NCT01070732CI-TRIAL-00003165APOTEL01completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The present study is aiming to unravel the clinical efficacy of intravenously administered paracetamol as antipyretic and analgesic medication in various medical conditions.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Analgesia | — | UNRESOLVED | — |
| Fever | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paracetamol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paracetamol
- description
- All patients will receive one single dose of 1000mg paracetamol.
- interventionNames
- Drug: Paracetamol
Primary outcomes (1)
- measure
- To evaluate the safety and efficacy of intravenously administered 1000mg ΑPOTEL® as antipyretic and analgesic medication.
- timeFrame
- One year
Secondary outcomes (2)
- measure
- Pharmacokinetics of paracetamol after intravenous infusion.
- timeFrame
- One year
- measure
- Effect of paracetamol after intravenous infusion in serum inflammatory mediators
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age greater than or equal to 18 years * Written informed consent by the patients * Medical condition necessitating the administration of antipyretic or analgesic medications Exclusion Criteria: * Αge lower than 18 years * Lack of informed consent * History of liver cirrhosis * Blood creatinine greater than 3mg/dl * Blood AST greater than 3 times the upper normal level according to the lab of the participating hospital * History of hypersensitivity to non-steroidal ant-inflammatory drugs * History of abuse of analgesics * Pregnancy or lactation * Fulminant hemorrhage of the upper or lower digestive tract * Thrombocytopenia defined as less than 50000 platelets/μl
References
Publications (3)
- BACKGROUNDTiippana E, Bachmann M, Kalso E, Pere P. Effect of paracetamol and coxib with or without dexamethasone after laparoscopic cholecystectomy. Acta Anaesthesiol Scand. 2008 May;52(5):673-80. doi: 10.1111/j.1399-6576.2008.01650.x. PMID 18419721
- BACKGROUNDCakan T, Inan N, Culhaoglu S, Bakkal K, Basar H. Intravenous paracetamol improves the quality of postoperative analgesia but does not decrease narcotic requirements. J Neurosurg Anesthesiol. 2008 Jul;20(3):169-73. doi: 10.1097/ANA.0b013e3181705cfb. PMID 18580346
- BACKGROUNDGrundmann U, Wornle C, Biedler A, Kreuer S, Wrobel M, Wilhelm W. The efficacy of the non-opioid analgesics parecoxib, paracetamol and metamizol for postoperative pain relief after lumbar microdiscectomy. Anesth Analg. 2006 Jul;103(1):217-22, table of contents. doi: 10.1213/01.ane.0000221438.08990.06. PMID 16790656