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An Open-label Non-randomized Phase IV Trial of the Clinical Efficacy of Intravenously Administered 1000mg Paracetamol as Antipyretic and Analgesic Medication

Phase 4
18 Years
Not Enrolling
Fever, Analgesia

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Trial Information

An Open-label Non-randomized Phase IV Trial of the Clinical Efficacy of Intravenously Administered 1000mg Paracetamol as Antipyretic and Analgesic Medication

Although modern therapeutics is targeting at prolongation of survival, despite the
underlying illness, it also aims at the improvement of the quality of life. Two major
symptoms affect considerably quality of life, fever and pain. Both symptoms are common
denominators of a vast number of clinical situations some of which have good prognosis and
some of which do not have. Among them situations like infectious diseases, hematologic
malignancies, solid tumor malignancies, connective tissue disorders and factors connected to
surgical operations predominate. Post-operative pain extents too long and imposes severely
on the post-operative course of the patient.

A variety of compounds have been developed for the management of fever and pain, the most
successful being non-steroidal anti-inflammatory drugs. They exist in a variety of forms for
various types of administration. Those administered parenterally are considered more
efficacious than those administered orally in terms of the rate of the achieved clinical
effect. Furthermore, several conditions necessitate parenteral administration.

Paracetamol is a well-known antipyretic and analgesic compound available for many years for
oral administration since intravenous infusion was hampered by water insolubility. Its
pro-drug, namely, pro-paracetamol, was applied for intravenous infusion where an amount of
2g was equally potent to 1 g of paracetamol. Pro-paracetamol has been given with success as
analgesic medication in women undergoing laparoscopic operation, as antipyretic in patients
with hematologic malignancies, as antipyretic in children bearing infectious diseases and as
antipyretic in critically ill patients.

Ready-made paracetamol for intravenous infusion has been in the market in some European
countries. It has been tested in four clinical trials. In the first trial it was given as
post-operative analgesia at a dose of 1g x 4 in 80 patients undergoing laparoscopic
cholecystectomy. Clinical efficacy was comparable to parecoxib and valdecoxib. In three
other studies, it was given as post-operative analgesia after spinal body ectomy and after
resection of the third mole providing conflicting results. However, in all the three latter
studies, the number of patients given paracetamol was limited.

In Greece, paracetamol for intravenous infusion at vials of 1g/6.7ml is manufactured by the
company Uni-Pharma (ΑPOTEL®). Based on: a) the limited number of patients enrolled in the
studies mentioned earlier, and b) the application of that form only after laparoscopic
cholecystectomy and spinal body ectomy, the present study is aiming to unravel the clinical
efficacy of the above formula of 1g intravenous paracetamol as antipyretic and analgesic
medication in various medical conditions.

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

To evaluate the safety and efficacy of intravenously administered 1000mg ΑPOTEL® as antipyretic and analgesic medication.

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Evangelos J Giamarellos-Bourboulis, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Athens, Medical School


Greece: Ethics Committee

Study ID:




Start Date:

January 2010

Completion Date:

January 2010

Related Keywords:

  • Fever
  • Analgesia
  • Fever
  • Infectious diseases
  • Neoplasia
  • Pain
  • cholecystectomy
  • Colectomy
  • Fever