Chan DK, Parikh SR Perioperative ketorolac increases post-tonsillectomy hemorrhage in adults but not children. Laryngoscope. 2014 Aug;124(8):1789-93. doi: 10.1002/lary.24555. Epub 2014 May 27. Review.
Drover DR, Hammer GB, Anderson BJ The pharmacokinetics of ketorolac after single postoperative intranasal administration in adolescent patients. Anesth Analg. 2012 Jun;114(6):1270-6. doi: 10.1213/ANE.0b013e31824f92c2. Epub 2012 Mar 30.
Gupta A, Daggett C, Ludwick J, Wells W, Lewis A Ketorolac after congenital heart surgery: does it increase the risk of significant bleeding complications? Paediatr Anaesth. 2005 Feb;15(2):139-42.
Judkins JH, Dray TG, Hubbell RN Intraoperative ketorolac and posttonsillectomy bleeding. Arch Otolaryngol Head Neck Surg. 1996 Sep;122(9):937-40.
Ketorolac National Cancer Institute Drug Dictionary.
Ketorolac , Drug Facts and Comparisons 4.0 (online). I. Wolters Kluwer Health, Editor. 2011.
Lane JC, Dworkin-Valenti J, Chiodo L, Haupert M Postoperative tonsillectomy bleeding complications in children: A comparison of three surgical techniques. Int J Pediatr Otorhinolaryngol. 2016 Sep;88:184-8. doi: 10.1016/j.ijporl.2016.07.007. Epub 2016 Jul 11.
Lieh-Lai MW, Kauffman RE, Uy HG, Danjin M, Simpson PM A randomized comparison of ketorolac tromethamine and morphine for postoperative analgesia in critically ill children. Crit Care Med. 1999 Dec;27(12):2786-91.
Lynn AM, Bradford H, Kantor ED, Andrew M, Vicini P, Anderson GD Ketorolac tromethamine: stereo-specific pharmacokinetics and single-dose use in postoperative infants aged 2-6 months. Paediatr Anaesth. 2011 Mar;21(3):325-34. doi: 10.1111/j.1460-9592.2010.03484.x. Epub 2010 Dec 29.
Moodie JE, Brown CR, Bisley EJ, Weber HU, Bynum L The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Anesth Analg. 2008 Dec;107(6):2025-31. doi: 10.1213/ane.0b013e318188b736. Erratum in: Anesth Analg. 2009 Mar;108(3):991. Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text.
Pappas AL, Fluder EM, Creech S, Hotaling A, Park A Postoperative analgesia in children undergoing myringotomy and placement equalization tubes in ambulatory surgery. Anesth Analg. 2003 Jun;96(6):1621-4, table of contents.
Riggin L, Ramakrishna J, Sommer DD, Koren G A 2013 updated systematic review & meta-analysis of 36 randomized controlled trials; no apparent effects of non steroidal anti-inflammatory agents on the risk of bleeding after tonsillectomy. Clin Otolaryngol. 2013 Apr;38(2):115-29. doi: 10.1111/coa.12106. Review.
Windfuhr JP, Chen YS, Remmert S Hemorrhage following tonsillectomy and adenoidectomy in 15,218 patients. Otolaryngol Head Neck Surg. 2005 Feb;132(2):281-6.
Zuppa AF, Mondick JT, Davis L, Cohen D Population pharmacokinetics of ketorolac in neonates and young infants. Am J Ther. 2009 Mar-Apr;16(2):143-6. doi: 10.1097/MJT.0b013e31818071df.
A Randomized, Double-blinded, Placebo-controlled Study of Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy
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.