The Use of ADV6209 for Premedication in Pediatric Anesthesia

Summary

To evaluate the effect of ADV6209, a new oral Midazolam formulation, on preoperative anxiety and sedation levels in paediatric anaesthesia Primary Objective: Sedation score (mYPAS) 30 min after administration of the premedication drug Secondary Objective: Acceptance of anaesthesia mask induction Acceptance of oral administration of the premedication drug

Timeline

Start

2020-11-16

Primary completion

2021-09-17

Completion

2021-09-17

Publications

• Background Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
• Background Kain ZN, Caldwell-Andrews AA, Krivutza DM, Weinberg ME, Wang SM, Gaal D. Trends in the practice of parental presence during induction of anesthesia and the use of preoperative sedative premedication in the United States, 1995-2002: results of a follow-up national survey. Anesth Analg. 2004 May;98(5):1252-9, table of contents. doi: 10.1213/01.ane.0000111183.38618.d8.
• Background Marcon F, Mathiron D, Pilard S, Lemaire-Hurtel AS, Dubaele JM, Djedaini-Pilard F. Development and formulation of a 0.2% oral solution of midazolam containing gamma-cyclodextrin. Int J Pharm. 2009 Sep 11;379(2):244-50. doi: 10.1016/j.ijpharm.2009.05.029. Epub 2009 May 23.
• Background Cuzzocrea F, Gugliandolo MC, Larcan R, Romeo C, Turiaco N, Dominici T. A psychological preoperative program: effects on anxiety and cooperative behaviors. Paediatr Anaesth. 2013 Feb;23(2):139-43. doi: 10.1111/pan.12100.
• Background Davidson AJ, Shrivastava PP, Jamsen K, Huang GH, Czarnecki C, Gibson MA, Stewart SA, Stargatt R. Risk factors for anxiety at induction of anesthesia in children: a prospective cohort study. Paediatr Anaesth. 2006 Sep;16(9):919-27. doi: 10.1111/j.1460-9592.2006.01904.x.
• Background Fortier MA, MacLaren JE, Martin SR, Perret-Karimi D, Kain ZN. Pediatric pain after ambulatory surgery: where's the medication? Pediatrics. 2009 Oct;124(4):e588-95. doi: 10.1542/peds.2008-3529. Epub 2009 Sep 7.
• Background Fortier MA, Del Rosario AM, Martin SR, Kain ZN. Perioperative anxiety in children. Paediatr Anaesth. 2010 Apr;20(4):318-22. doi: 10.1111/j.1460-9592.2010.03263.x. Epub 2010 Feb 23.
• Background Marcon F, Guittet C, Manso MA, Burton I, Granier LA, Jacqmin P, Dupont H. Population pharmacokinetic evaluation of ADV6209, an innovative oral solution of midazolam containing cyclodextrin. Eur J Pharm Sci. 2018 Mar 1;114:46-54. doi: 10.1016/j.ejps.2017.11.030. Epub 2017 Dec 5.
• Background Huet A, Lucas-Polomeni MM, Robert JC, Sixou JL, Wodey E. Hypnosis and dental anesthesia in children: a prospective controlled study. Int J Clin Exp Hypn. 2011 Oct-Dec;59(4):424-40. doi: 10.1080/00207144.2011.594740.
• Background Weldon BC, Bell M, Craddock T. The effect of caudal analgesia on emergence agitation in children after sevoflurane versus halothane anesthesia. Anesth Analg. 2004 Feb;98(2):321-326. doi: 10.1213/01.ANE.0000096004.96603.08.
• Background Schulz KF, Altman DG, Moher D, Fergusson D. CONSORT 2010 changes and testing blindness in RCTs. Lancet. 2010 Apr 3;375(9721):1144-6. doi: 10.1016/S0140-6736(10)60413-8. Epub 2010 Mar 24. No abstract available.

Drugs

Indications

No indication recorded.