Paracetamol as Antipyretic and Analgesic Medication (APOTEL01)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||An Open-label Non-randomized Phase IV Trial of the Clinical Efficacy of Intravenously Administered 1000mg Paracetamol as Antipyretic and Analgesic Medication|
- To evaluate the safety and efficacy of intravenously administered 1000mg ΑPOTEL® as antipyretic and analgesic medication. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- Pharmacokinetics of paracetamol after intravenous infusion. [ Time Frame: One year ] [ Designated as safety issue: No ]
- Effect of paracetamol after intravenous infusion in serum inflammatory mediators [ Time Frame: One year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
All patients will receive one single dose of 1000mg paracetamol.
All patients will receive one single dose of 1000mg paracetamol. If considered mandatory by the attending physician, similar doses may be administered latter for a maximum period of five days. The maximum allowed daily dose is 3000mg. If the attending physician believes that after the administration of at least of three doses the desired analgesic or antipyretic effect is not achieved, he may administer any other compound in his will.
Other Name: ΑPOTEL®
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070732
|4th Department of Internal Medicine, ATTIKON University Hospital|
|Athens, Greece, 12462|
|2nd Department of Medicine, Sismanogleion General Hospital|
|Athens, Greece, 15526|
|2nd Department of Surgery, G. Gennimatas General Hospital|
|Study Chair:||Evangelos J Giamarellos-Bourboulis, MD, PhD||University of Athens, Medical School|
|Principal Investigator:||Helen Giamarellou, MD, PhD||ATTIKON University Hospital of Athens|
|Principal Investigator:||George Koratzanis, MD, PhD||Sismanogelion General Hospital, Athens|
|Principal Investigator:||Konstantinos Atmatzidis, MD, PhD||G.Gennimatas General Hospital of Thessaloniki|