The MEOPAeDent trial protocol-an observational study of the Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) effects in paediatric dentistry

Tony Prud'homme, Sylvie Dajean-Trutaud, Morgane Rousselet, Fanny Feuillet, Marjorie Carpentier-Cheraud, Olivier Bonnot, Isabelle Hyon, Marie Grall-Bronnec, Serena Lopez-Cazaux, Caroline Victorri-Vigneau, Tony Prud'homme, Sylvie Dajean-Trutaud, Morgane Rousselet, Fanny Feuillet, Marjorie Carpentier-Cheraud, Olivier Bonnot, Isabelle Hyon, Marie Grall-Bronnec, Serena Lopez-Cazaux, Caroline Victorri-Vigneau

Abstract

Background: Many studies were conducted to assess the benefit/risk ratio of EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) in France before it was authorized for use outside the hospital setting in 2009. The main objective of this project is to evaluate the effects sought and felt by children when EMONO is used in paediatric dentistry. The secondary objectives are to (i) evaluate the appreciation of EMONO by the children, (ii) characterize children who experience both analgesia and anxiolysis, (iii) evaluate children's appetite for EMONO and characterize children with a high appetite and (iv) evaluate the impact of the difference in practice among the French dental service university hospitals on anxiety. The maintenance of a framework for the safe use of this drug, whose place in dental care is fundamental, is essential. Twelve of the 16 French dental service university hospitals agreed to participate in this study.

Methods: MEOPAeDent is an observational, descriptive, transversal study that aims to evaluate the effects sought and felt by children when EMONO is used in paediatric dentistry. Subjects requiring dental care under EMONO are recruited by 12 French dental service university hospitals. Patients aged from 3 to 15 years are recruited for the study when they visit a dental service of a French university hospital requiring dental care under EMONO. The investigator collects the necessary data from the child's medical records, from his own observations and from questions posed to the child and his/her parents. A survey is completed at the first and final sessions of dental care under EMONO.

Discussion: This study will provide an evaluation of the effects of EMONO on the French paediatric population in need of dental care as well as evaluate the appetite for the use of this substance. The results will first be used to provide additional data that is essential to monitor the use of a product with an authorization to use it outside of hospitals from 2009 in France, confirm its safety for use and justify its framework of application.

Trial registration: ClinicalTrials.gov ID: NCT03453411 registered 2 March 2018.

Keywords: Equimolar mixture of oxygen and nitrous oxide (EMONO); Observational study; Substance-related disorders.

Conflict of interest statement

Ethics approval and consent to participate

This non-interventional study has been declared to the French Data Protection Body (CNIL) and received a favourable opinion from a Committee for the Protection of Persons.

At inclusion, the patients receive an information leaflet for their age range, as well as the parents or legal guardian. The investigator will note in the patient’s file that he/she and the parents have been orally informed, received the briefing note and provided their oral consent to participate in the research. At least one parent of all children, regardless of the age of the child, must be informed and must consent.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

    1. Hopkins PM. Nitrous oxide: a unique drug of continuing importance for anaesthesia. Best Pract Res Clin Anaesthesiol. 2005;19(3):381–389.
    1. Wilson KE. Overview of paediatric dental sedation: 2. Nitrous oxide/oxygen inhalation sedation. Dent Update. 2013;40(10):822–824.
    1. Brunick A, Clark MS. Nitrous oxide and oxygen sedation: an update. Dent Assist. 2013;82(4):12.
    1. Craig DC, Wildsmith JA. Conscious sedation for dentistry: an update. Br Dent J. 2007;203(11):629–631.
    1. Holroyd I, Roberts GJ. Inhalation sedation with nitrous oxide: a review. Dent Update. 2000;27(3):141.
    1. Hennequin M, Collado V, Faulks D, Koscielny S, Onody P, Nicolas E. A clinical trial of efficacy and safety of inhalation sedation with a 50% nitrous oxide/oxygen premix (Kalinox) in general practice. Clin Oral Investig. 2012;16(2):633–642.
    1. Annequin D, Carbajal R, Chauvin P, Gall O, Tourniaire B, Murat I. Fixed 50% nitrous oxide oxygen mixture for painful procedures: a French survey. Pediatrics. 2000;105(4):E47.
    1. Dohrn CS, Lichtor JL, Coalson DW, Uitvlugt A, de Wit H, Zacny JP. Reinforcing effects of extended inhalation of nitrous oxide in humans. Drug Alcohol Depend. 1993;31(3):265–280.
    1. Onody P, Gil P, Hennequin M. Safety of inhalation of a 50% nitrous oxide/oxygen premix: a prospective survey of 35 828 administrations. Drug Saf. 2006;29(7):633–640.
    1. Collado V, Nicolas E, Faulks D, Tardieu C, Manière MC, Droz D, Onody P, Hennequin M. Evaluation of safe and effective administration of nitrous oxide after a postgraduate training course. BMC Clin Pharmacol. 2008;8:3.
    1. Wu MS, Hsu YD, Lin JC, Chen SC, Lee JT. Spinal myoclonus in subacute combined degeneration caused by nitrous oxide intoxication. Acta Neurol Taiwanica. 2007;16(2):102–105.
    1. Winek CL, Wahba WW, Rozin L. Accidental death by nitrous oxide inhalation. Forensic Sci Int. 1995;73(2):139–141.
    1. Waters MF, Kang GA, Mazziotta JC, DeGiorgio CM. Nitrous oxide inhalation as a cause of cervical myelopathy. Acta Neurol Scand. 2005;112(4):270–272.
    1. Wagner SA, Clark MA, Wesche DL, Doedens DJ, Lloyd AW. Asphyxial deaths from the recreational use of nitrous oxide. J Forensic Sci. 1992;37(4):1008–1015.
    1. Waclawik AJ, Luzzio CC, Juhasz-Pocsine K, Hamilton V. Myeloneuropathy from nitrous oxide abuse: unusually high methylmalonic acid and homocysteine levels. WMJ. 2003;102(4):43–45.
    1. Temple WA, Beasley DM, Baker DJ. Nitrous oxide abuse from whipped cream dispenser chargers. N Z Med J. 1997;110(1050):322–323.
    1. Suruda AJ, McGlothlin JD. Fatal abuse of nitrous oxide in the workplace. J Occup Med. 1990;32(8):682–684.
    1. Sterman AB, Coyle PK. Subacute toxic delirium following nitrous oxide abuse. Arch Neurol. 1983;40(7):446–447.
    1. Shulman RM, Geraghty TJ, Tadros M. A case of unusual substance abuse causing myeloneuropathy. Spinal Cord. 2007;45(4):314–317.
    1. Sethi NK, Mullin P, Torgovnick J, Capasso G. Nitrous oxide "whippit" abuse presenting with cobalamin responsive psychosis. J Med Toxicol. 2006;2(2):71–74.
    1. Sahenk Z, Mendell JR, Couri D, Nachtman J. Polyneuropathy from inhalation of N2O cartridges through a whipped-cream dispenser. Neurology. 1978;28(5):485–487.
    1. Richardson PG. Peripheral neuropathy following nitrous oxide abuse. Emerg Med Australas. 2010;22(1):88–90.
    1. Nevins MA. Neuropathy after nitrous oxide abuse. JAMA. 1980;244(20):2264.
    1. Miller MA, Martinez V, McCarthy R, Patel MM. Nitrous oxide "whippit" abuse presenting as clinical B12 deficiency and ataxia. Am J Emerg Med. 2004;22(2):124.
    1. Layzer RB, Fishman RA, Schafer JA. Neuropathy following abuse of nitrous oxide. Neurology. 1978;28(5):504–506.
    1. Layzer RB. Myeloneuropathy after prolonged exposure to nitrous oxide. Lancet. 1978;2(8102):1227–1230.
    1. Iwata K, O'Keefe GB, Karanas A. Neurologic problems associated with chronic nitrous oxide abuse in a non-healthcare worker. Am J Med Sci. 2001;322(3):173–174.
    1. Hwang JC, Himel HN, Edlich RF. Frostbite of the face after recreational misuse of nitrous oxide. Burns. 1996;22(2):152–153.
    1. Gutmann L, Johnsen D. Nitrous oxide-induced myeloneuropathy: report of cases. J Am Dent Assoc. 1981;103(2):239–241.
    1. Garbaz L, Mispelaere D, Boutemy M, Jounieaux V. Pneumothorax following recreational inhalation of nitrous oxide. Rev Mal Respir. 2007;24(5):622–624.
    1. Diamond AL, Diamond R, Freedman SM, Thomas FP. "whippets"-induced cobalamin deficiency manifesting as cervical myelopathy. J Neuroimaging. 2004;14(3):277–280.
    1. Chadly A, Marc B, Barres D, Durigon M. Suicide by nitrous oxide poisoning. Am J Forensic Med Pathol. 1989;10(4):330–331.
    1. Cartner M, Sinnott M, Silburn P. Paralysis caused by "nagging". Med J Aust. 2007;187(6):366–367.
    1. Butzkueven H, King JO. Nitrous oxide myelopathy in an abuser of whipped cream bulbs. J Clin Neurosci. 2000;7(1):73–75.
    1. Brett A. Myeloneuropathy from whipped cream bulbs presenting as conversion disorder. Aust N Z J Psychiatry. 1997;31(1):131–132.
    1. Blanco G, Peters HA. Myeloneuropathy and macrocytosis associated with nitrous oxide abuse. Arch Neurol. 1983;40(7):416–418.
    1. Alt RS, Morrissey RP, Gang MA, Hoffman RS, Schaumburg HH. Severe myeloneuropathy from acute high-dose nitrous oxide (N(2)O) abuse. J Emerg Med. 2011;41(4):378–80.
    1. Evans SM, Funderburk FR, Griffiths RR. Zolpidem and triazolam in humans: behavioral and subjective effects and abuse liability. J Pharmacol Exp Ther. 1990;255(3):1246–55.
    1. Griffiths RR, Bigelow GE, Ator NA. Principles of initial experimental drug abuse liability assessment in humans. Drug Alcohol Depend. 2003;70(3 Suppl):S41–S54.
    1. Weaver JM, Schofield TJ. Mediation and moderation of divorce effects on children's behavior problems. J Fam Psychol. 2015;29(1):39–48.
    1. Koskenvuo K, Koskenvuo M. Childhood adversities predict strongly the use of psychotropic drugs in adulthood: a population-based cohort study of 24,284 Finns. J Epidemiol Community Health. 2015;69(4):354–360.
    1. Lara A, Crego A, Romero-Maroto M. Emotional contagion of dental fear to children: the fathers' mediating role in parental transfer of fear. Int J Paediatr Dent. 2012;22(5):324–330.
    1. Prud’homme T, Nizard J, Dajean-Trutaud S, Grall-Bronnec M, Victorri-Vigneau C. Interest of nitrous oxide as an analgesic in dental care. Poster on the World Congress on Pain 2016 (Yokohama).

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren