Paracetamol as Antipyretic and Analgesic Medication

NCT01070732 | Completed Phase 4

• 1 other identifier: APOTEL01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

The present study is aiming to unravel the clinical efficacy of intravenously administered paracetamol as antipyretic and analgesic medication in various medical conditions.

Conditions

Fever; Analgesia

Keywords

Fever; Infectious diseases; Neoplasia; Pain; cholecystectomy; Colectomy

Outcome Measures

Primary Outcomes (1)

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

  One year

Secondary Outcomes (2)

• Pharmacokinetics of paracetamol after intravenous infusion.

  One year

• Effect of paracetamol after intravenous infusion in serum inflammatory mediators

  One year

Study Arms (1)

Paracetamol

EXPERIMENTAL

All patients will receive one single dose of 1000mg paracetamol.

Drug: Paracetamol

Interventions

Paracetamol DRUG

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.

Also known as: ΑPOTEL®

Paracetamol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years
• Written informed consent by the patients
• Medical condition necessitating the administration of antipyretic or analgesic medications

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (3)

4th Department of Internal Medicine, ATTIKON University Hospital

Athens, 12462, Greece

Location

2nd Department of Medicine, Sismanogleion General Hospital

Athens, 15526, Greece

Location

2nd Department of Surgery, G. Gennimatas General Hospital

Thessaloniki, Greece

Location

Related Publications (3)

• Tiippana 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 BACKGROUND

• Cakan 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 BACKGROUND

• Grundmann 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 BACKGROUND

MeSH Terms

Conditions

Fever; Agnosia; Communicable Diseases; Neoplasms; Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Infections; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Evangelos J Giamarellos-Bourboulis, MD, PhD

  University of Athens, Medical School

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 18, 2010

Record last verified: 2010-02

Locations

GR (3)