Pain, Postoperative — Inhaled Nebulised S(+)-Ketamine for Postoperative Analgesia
Citation(s)
Aan Het Rot M, Zarate CA Jr, Charney DS, Mathew SJ Ketamine for depression: where do we go from here? Biol Psychiatry. 2012 Oct 1;72(7):537-47. doi: 10.1016/j.biopsych.2012.05.003. Epub 2012 Jun 16. Review.
Aroni F, Iacovidou N, Dontas I, Pourzitaki C, Xanthos T Pharmacological aspects and potential new clinical applications of ketamine: reevaluation of an old drug. J Clin Pharmacol. 2009 Aug;49(8):957-64. doi: 10.1177/0091270009337941. Epub 2009 Jun 22.
Chong C, Schug SA, Page-Sharp M, Jenkins B, Ilett KF Development of a sublingual/oral formulation of ketamine for use in neuropathic pain: Preliminary findings from a three-way randomized, crossover study. Clin Drug Investig. 2009;29(5):317-24. doi: 10.2165/00044011-200929050-00004.
Clements JA, Nimmo WS Pharmacokinetics and analgesic effect of ketamine in man. Br J Anaesth. 1981 Jan;53(1):27-30.
Craven R Ketamine. Anaesthesia. 2007 Dec;62 Suppl 1:48-53. Review.
Dal D, Celebi N, Elvan EG, Celiker V, Aypar U The efficacy of intravenous or peritonsillar infiltration of ketamine for postoperative pain relief in children following adenotonsillectomy. Paediatr Anaesth. 2007 Mar;17(3):263-9.
DOMINO EF, CHODOFF P, CORSSEN G PHARMACOLOGIC EFFECTS OF CI-581, A NEW DISSOCIATIVE ANESTHETIC, IN MAN. Clin Pharmacol Ther. 1965 May-Jun;6:279-91.
European Medicines Agency Guideline for good clinical practice 2002. www.ema.com.eu. Accessed 8/1, 2012.
Zhu MM, Zhou QH, Zhu MH, Rong HB, Xu YM, Qian YN, Fu CZ Effects of nebulized ketamine on allergen-induced airway hyperresponsiveness and inflammation in actively sensitized Brown-Norway rats. J Inflamm (Lond). 2007 May 4;4:10.
Inhaled Nebulised S(+)-Ketamine for Postoperative Analgesia
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.