Critical Illness — Safety and Efficacy of Acetaminophen in the Intensive Care Unit.
Citation(s)
Allegaert K, Naulaers G Haemodynamics of intravenous paracetamol in neonates. Eur J Clin Pharmacol. 2010 Sep;66(9):855-8. doi: 10.1007/s00228-010-0860-z. Epub 2010 Jul 4.
Bendjelid K, Soubirou JL, Bohe J [Systemic arterial hypotension induced by paracetamol administration: nurse's anecdotes or facts from the intensive care unit?]. Ann Fr Anesth Reanim. 2000 Jun;19(6):499. French.
Boyle M, Hundy S, Torda TA Paracetamol administration is associated with hypotension in the critically ill. Aust Crit Care. 1997 Dec;10(4):120-2.
Cruz P, Garutti I, Díaz S, Fernández-Quero L [Metamizol versus propacetamol: comparative study of the hemodynamic and antipyretic effects in critically ill patients]. Rev Esp Anestesiol Reanim. 2002 Oct;49(8):391-6. Spanish.
de Maat MM, Tijssen TA, Brüggemann RJ, Ponssen HH Paracetamol for intravenous use in medium--and intensive care patients: pharmacokinetics and tolerance. Eur J Clin Pharmacol. 2010 Jul;66(7):713-9. doi: 10.1007/s00228-010-0806-5. Epub 2010 Mar 19.
Hersch M, Raveh D, Izbicki G Effect of intravenous propacetamol on blood pressure in febrile critically ill patients. Pharmacotherapy. 2008 Oct;28(10):1205-10. doi: 10.1592/phco.28.10.1205.
Krajcová A, Matoušek V, Duška F Mechanism of paracetamol-induced hypotension in critically ill patients: a prospective observational cross-over study. Aust Crit Care. 2013 Aug;26(3):136-41. doi: 10.1016/j.aucc.2012.02.002. Epub 2012 Mar 14.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
