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                                          • Inhalation sedation with nitrous oxide in dentistry

                                          Inhalation sedation with nitrous oxide in dentistry

                                          Fotolia-82419510-m
                                          Research area: High tech medicine

                                          Duration: April 2018 – November 2018
                                          Topic submitted by: Federation of Austrian Social Security Institutions
                                          Language: German
                                          Publication: LBI-HTA Project report No. 105: https://eprints.aihta.at/1182/

                                          Background:
                                          The treatment of pain and anxiety is of major importance in dentistry (~10 to 30% of patients are afraid of dental treatment).[i] According to the Council of European Dentists (CED), inhaled sedation with nitrous oxide (N2O) is considered to be a proven and safe method of managing anxiety and pain in dentistry (mainly for anxious and/ or very young patients).[ii] In addition to the anxiolytic effect, N2O also has an analgesic and sedative effect. Inhaled sedation with N2O is established in many countries and is very common in Anglo-Saxon and Scandinavian countries. It is cited by the European Academy of Paediatric Dentistry (EAPD) as the sedation method of first-choice.[iii]

                                          In Austria, inhaled sedation with N2O is precluded by a restricted recommendation from the Supreme Medical Council (OSR). The OSR recommended to the BMGF (Dec. 2016) that N2O should only be used under certain conditions in primary care. Since these conditions are not feasible in primary care, the use of N2O sedation by dentists should not be allowed in Austria (anaesthesia restriction of the OSR).

                                          Aim of the project:
                                          The aim of the project is to investigate on the one hand, which policies regarding inhalation sedation with N2O in dentistry are available in Europe (focusing on countries such as Germany, Switzerland, the Netherlands and Sweden) and to provide information on:

                                          • the training for a safe use of inhalation sedation with N2O, as well as
                                          • to identify or define the use of inhalation sedation with N2O by dentists in European countries without anaesthesia restriction.

                                          On the other hand, a systematic analysis of the efficacy and safety of inhalation sedation with N2O in dentistry should be carried out.

                                          Research questions:
                                          The following questions should be answered:

                                          1. Efficacy and safety of the inhalation sedation with N2O: Is inhalation sedation with N2O for the treatment of patients with a condition where a minimal to moderate sedation is feasible more effective and safer (or at least as effective and safe) in terms of defined outcome measures (see PICO) compared to other sedatives or no sedation?
                                          • What is the harmless mixing ratio of N2O for the use in the dental sector?
                                          • What are the risks of inhalation sedation with N2O? Can habituation effects be observed?
                                          • To what extent can the dental personnel be affected by inhalation sedation with N2O?
                                          • What are the benefits of inhalation sedation with N2O compared to conventional anaesthesia at the dentist in connection with the actual treatment (improvement of the quality of the treatment, time factor of the treatment)? What are the disadvantages of inhalation sedation with N2O?
                                          1. Organisational and legal aspects: Under what conditions can inhalation sedation with N2O be used in anxiety patients (especially children) without anaesthesiologists?
                                          • Under what conditions is inhalation sedation with N2O recommended and used in other European countries? In which European countries can inhalation sedation with N2O be used without anaesthesia restrictions by dentists?
                                          • What are the criteria for the application? What is the process to be followed for N2O inhalation sedation? What are the necessary reproaches for emergency situations?
                                          • What training is required for a safe use of inhalation sedation with N2O?
                                          • Which groups of people are suitable for an application? When should an application not be performed?

                                          Methods:
                                          Systematic search of literature and sources:

                                          • To answer research question 1): systematic review based on systematic literature search in several databases, manual search in references (where applicable by means of Scopus);
                                          • To answer research question 2): manual search for (profession) guidelines / directives in dentistry of European countries regarding the use of inhalation sedation with N2O in dentistry, required training, etc.; contacting suppliers/ manufacturers of inhalation sedation devices for N2O-handling guidelines, inclusion/ contra-indications;

                                          Systematic presentation of results:

                                          • To answer research question 1): systematic review of results on efficacy and safety (based on EUnetHTA Core Model for Rapid Assessments), risk of bias assessment, data extraction
                                          • To answer research question 1): presentation of European recommendations from (profession) guidelines/ directives in dentistry
                                          • Recommendation on research questions 1) + 2): derivation of a recommendation based on the included literature (strength of evidence [GRADE]) and European standards

                                          PICO question:

                                          Population

                                          Patients with indication for inhalation sedation with nitrous oxide

                                          (e.g., anxious, but cooperative children/young people, patients with dental fears or severe retching, short plannable treatment duration, etc.)

                                          Intervention

                                          Inhalation sedation with nitrous oxide in dentistry

                                          Control

                                          Other sedatives (if available) or no sedation

                                          Outcome

                                          RCTs/NRCTs/prospective trials:

                                          Efficacy endpoints:

                                          • Patient satisfaction (compliance)
                                          • Quality of life
                                            • Anxiety (level of anxiety/ anxiety state)
                                            • Pain (sensitivity to pain during treatment)
                                          • Improvement of treatment quality
                                          • Duration of treatment (time factor)
                                          • and others

                                          Safety endpoints:

                                          • Complications during treatment (e.g., loss of consciousness, overdose [due to diffusion hypoxemia], mortality etc.)
                                          • Complications after treatment (e.g., pain, nausea, sickness, fatigue, overpressure of the middle ear, flatulence etc.)
                                          • Complications /impairment of the dental personnel

                                          (profession) guidelines/ directives in dentistry:

                                          • Information on the procedure/ process of inhalation sedation with N2O in dentistry
                                          • Required training

                                          Setting

                                          Dental practitioners;

                                          Industrial countries (Europe) – for policy search

                                          Study design

                                          Randomized controlled trials with ? 10 patients (for efficacy and safety),

                                          In absence of RCTs: non-randomized controlled trials with ? 10 patients (for efficacy and safety),

                                          In absence of NRCTs: prospective trials with ? 10 patients (for safety);

                                          Language: English and German

                                          Publication period

                                          No limitation

                                           

                                          Timetable / milestones:

                                          April – May

                                          Scoping, preparation of the project record

                                          May – June

                                          Web search, systematic literature search, selection and acquisition of literature, preparation of extraction tables

                                          July – September

                                          Data extraction, synthesis and grading quality of evidence, writing of the project report

                                          October – November

                                          Internal and external review, finalizing, publication of the project report

                                           


                                          [i] Österreichische Gesellschaft für Kinderzahnheilkunde (ÖGK). Standards und Richtlinien zur inhalativen Lachgassedierung in der Zahnmedizin.

                                          [ii] Council of European Dentists (CED). Anwendung der inhalativen Lachgassedierung in der Zahnmedizin. 2012. Verfügbar unter: www.eudental.eu.

                                          [iii] Esch J. Lachgas in der Kinderzahnheilkunde. Deutsche Zahnärztliche Zeitschrift, 2013, 68 (8).

                                           

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