Inhalation sedation with nitrous oxide in dentistry

Duration: April 2018 – November 2018
Topic submitted by: Federation of Austrian Social Security Institutions
Language: German
Publication: LBI-HTA Project report No. 105: http://eprints.hta.lbg.ac.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?

2. 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:

Timetable / milestones: