The Use of ADV6209 for Premedication in Pediatric Anesthesia

NCT03931057 | Completed Phase 4

• 1 other identifier: 1.4-22.07.2019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Preanesthetic Medication

Outcome Measures

Primary Outcomes (1)

• Change from baseline of the sedation score (modified Yale Preoperative Anxiety Scale - mYPAS-short form) at 30 minutes after administration of the premedication drug

  The mYPAS-SF consists of four items (activity, vocalizations, emotional expressivity and state of apparent arousal). Each domain consists of Likert-type response options reflecting behaviours. Children's behaviour is rated from 1 to 4 or 1 to 6 (depending on the domain), with higher numbers indicating the highest severity within that domain

  The level of sedation 1 minute before the premedication will be graded and compared to the level of sedation 30 minutes after the oral administration of the drug

Secondary Outcomes (2)

• Acceptance of oral administration of the premedication drugs

  Will be evaluated, when the children swallow the premedication drug - 30 minutes before the induction of anaesthesia

• Acceptance of anaesthesia mask induction

  Will be evaluated, when anaesthesia is induced with the anesthesia mask - 30 minutes after the premedication

Study Arms (2)

ADV6209

EXPERIMENTAL

ADV6209 (= gamma-cyclodextrin-Midazolam) 0.25 mg/kg p.o. once 30 min. before anesthesia

Drug: ADV6209 (=gamma-cyclodextrin-Midazolam)

Midazolam

ACTIVE COMPARATOR

Midazolam (in orange flavored syrup) 0.25 mg/kg p.o. once 30 min. before anesthesia

Drug: Midazolam

Interventions

ADV6209 (=gamma-cyclodextrin-Midazolam) DRUG

30 min. before anesthesia children have to swallow the anxiolytic drug (ADV6209)

Also known as: Ozalin (registered Tradename)

ADV6209

Midazolam DRUG

30 min. before anesthesia children have to swallow the anxiolytic drug Midazolam

Also known as: Dormicum (Tradename)

Midazolam

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA 1 and 2 children from 2-8 years scheduled for elective surgical or diagnostic procedures, where premedication would be used in clinical routine

You may not qualify if:

• ASA 3-5
• Allergy against the study drug
• Participation in another clinical study investigating another IMP within one month prior to screening
• Other objections to study participation in the opinion of the investigator
• Parent's or legal guardian's refusal of participation of the child

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Dept. of Anesthesia, Intensive Care Medicine and Pain Medicine

Vienna, 1090, Austria

Location

Related Publications (11)

• 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.

  PMID: 9322455 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.

  PMID: 15105196 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.

  PMID: 19467307 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.

  PMID: 23289773 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.

  PMID: 16918652 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.

  PMID: 19736260 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.

  PMID: 20199609 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.

  PMID: 29203151 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.

  PMID: 21867378 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.

  PMID: 14742362 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.

  PMID: 20338625 BACKGROUND

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Peter Marhofer, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, MD

Model Details: A controlled, randomized, double blinded study Study group 1 (40 children) ADV6209 0.25 mg/kg p.o. Study group 2 (40 children) Midazolam (in orange flavoured syrup) 0.25 mg/kg p.o.

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 29, 2019
• Study Start: November 16, 2020
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)