1. Benzodiazepines: A novel “route” to sedation for the anxious adolescent Kathy Wilson Senior Dental Officer & Honorary Staff Grade South Tyneside PCT & Newcastle Dental School

2. AIM OF PRESENTATION A presentation of current research into the field of benzodiazepine sedation for anxious adolescent dental patients

3. PRESENTATION u Guidelines for conscious sedation u Current sedation techniques u Benzodiazepine sedation u Current research

4. “The control of pain & anxiety is an integral part of dental practice.” General Dental Council 2001 Need for Sedation

5. “LA, supplemented where necessary by simple sedation, should be first choice for pain & anxiety control” Faculty of GDPs 1998 Need for Sedation

6. CONSCIOUS SEDATION “A technique in which the use of a drug or drugs produces a state of depression of the CNS enabling treatment to be carried out but during which verbal contact with the patient is maintained throughout the period of treatment” General Dental Council 2001

7. Current Guidelines u “A Conscious Decision” –DOH 2000 u “Maintaining Standards” – GDC 2001 u “Safe Sedation of Children undergoing Diagnostic and Therapeutic procedures” u “Conscious Sedation in the Provision of Dental Care” –SDAC 2003

8. “A Conscious Decision” u “A Conscious Decision” DOH 2000 u Emphasises the need to provide alternatives to GA for pain and anxiety management.

9. “Maintaining Standards” u “A dentist who assumes the dual responsibility of sedating the patient as well as providing treatment must:” u “be able to justify the use of the method selected with reference to current guidelines…” »GDC Maintaining Standards Nov 2001

10. “SIGN Guidelines” u “Safe Sedation of Children Undergoing Diagnostic and Therapeutic Procedures – A national clinical guideline” u Relates to those under age of 16 years u Published in Feb 2002 u www.sign.ac.uk

11. Main Recommendations: Dental Sedation u Nitrous oxide/oxygen inhalation sedation –“is recommended for use in all dental settings but particularly General Dental Practice and Community Dental Service”

12. Main Recommendations Dental Sedation u Intravenous Sedation –“Single agent sedation with midazolam is only recommended for IV dental sedation in patients over 16 years of age. IV sedation should be avoided in younger children in primary or community dental practice.”

13. Main Recommendations Dental Sedation u Other Routes –“other routes of drug administration including the oral, rectal and intra-nasal route have no advantages over inhalation and intravenous sedation and should be restricted to a hospital setting…”

14. “Conscious Sedation in the provision of Dental care” u Aim –“To lay down specific guidance for the practice of Conscious Sedation in general dental practice, community and hospital settings” –SDAC 2003

15. Main Recommendations for sedation in adolescents u Must only be undertaken by teams which have adequate training and experience u Nitrous oxide/oxygen should be first choice

16. Main Recommendations for sedation in adolescents u IV sedation only appropriate in a minority of cases u Oral/Intranasal/Transmucosal sedation should only be administered under appropriate circumstances by a practitioner experienced in their use

17. Current Sedation Practice u Sedation is considered a safe alternative to GA for dental procedures u Inhalation Sedation mainstay for those under the age of 16 u Chronic exposure to nitrous oxide u May not be accepted by some patients

18. Current Sedation Practice u A need to consider other forms of sedation u Benzodiazepines have favourable pharmacology u Limited research into the use of midazolam in dental patients under the age of 16 in UK

19. A study of the use of Benzodiazepines in adolescent dental patients

20. Midazolam u Most favourable pharmacology of BZDs u Used extensively in adults via the IV route u Limited use in those under 16 years u May provide an alternative where inhalation sedation contraindicated

21. Midazolam – clinical effects u Anxiolysis u Sedation u Muscle relaxation u Amnesia

22. Midazolam – side effects u Respiratory depression u Drug interactions –CNS depressants –Antibiotics –Antacids u Tolerance u Dis-inhibition

23. Advantages u Can be titrated (IV route) u Potent anxiolytic effect u Amnesia u Muscle relaxation

24. Disadvantages u May require IV cannulation u Length of appointment time u Side effects (minimal) u Dis-inhibition

25. Intravenous ?Inhalation ? Transmucosal ? Oral ?

26. A STUDY OF THE EFFECTIVENESS OF BUCCAL MIDAZOLAM SEDATION FOR ORTHODONTIC EXTRACTIONS Dr K E Wilson University of Newcastle upon Tyne

27. Aim of Research Project u Effectiveness and acceptability of midazolam for dental extractions in adolescent patients u Different routes researched –Oral (Anaesthesia 2002; 57: 860-867) –Intravenous (British Journal of Anaesthesia 2003 Dec) –Transmucosal

28. Transmucosal Sedation u Routes –Sublingual –Intranasal –Buccal –Rectal (not in UK) u Advantages –Rapid absorption –Avoids 1 st pass metabolism u Disadvantages –Taste –Irritation of tissues

29. Buccal Midazolam u Concentrated formulation – 10mg/ml u Produced by Special Products u Formulated for use in Epileptic Patients

30. METHOD u Prospective, randomised, crossover trial u 40 patients, aged 10 to 16 years, ASA I & II u Referred for orthodontic extractions

31. METHOD u Two treatment sessions –2 extractions - buccal midazolam sedation –2 extractions - nitrous oxide sedation u Children randomly allocated to receive nitrous oxide or midazolam at first visit u Information and consent at assessment

32. BUCCAL MIDAZOLAM SEDATION u Buccal midazolam (0.2mg/kg) 10-15 minutes pre-op u Monitored by sedation trained Dental Nurse u Treatment carried out (LA & Extractions) u Recovery u Discharged when fit

33. NITROUS OXIDE SEDATION u Nitrous oxide titrated 10% every minute (max 30%) u Treatment carried out (LA & Extractions) u Recovery u Discharged when fit

34. ASSESSMENT CRITERIA

35. PHYSIOLOGICAL STATUS u Baseline –BP, Pulse, Weight, Respiratory Rate, Oxygen Saturation u Every 2 minutes –Pulse, Respiratory Rate, Oxygen Saturation

36. LEVEL OF SEDATION u “Classification of Emotional Status” (Brietkopf & Buttner) u Recorded every 2 minutes u Four point scale 1 – irritated & awake 2 – awake & calm 3 – tired, hardly moving 4 – drowsy, without reaction but rousable

37. BEHAVIOUR DURING TREATMENT u “Frankl Behaviour Rating Scale” u Recorded every 2 minutes u Four point scale: 1 – Refusal / Distress 2 – Uncooperative / Reluctant 3 – Cooperative / Reserved 4 – Interested / Enjoyed

38. OUTCOME OF TREATEMTENT & OVERALL BEHAVIOUR u “Houpt Behaviour Rating Scale” u Recorded at end of visit u Six point scale: 1 – Aborted 4 – Good 2 – Poor 5 – Very good 3 – Fair 6 – Excellent

39. POST-OPERATIVELY  Post-operative Questionnaire –Recall of treatment –Same sedation again –Preference for sedation –Side effects

40. RECALL OF TREATMENT u Patients were asked if they could remember: –Receiving the local anaesthetic –Having the extractions carried out –Being in recovery

41. PATIENT’S OPINION OF TREATMENT u Patients were asked: – Would you have this sedation again? –Which type of sedation did you prefer?

42. RESULTS

43. SUBJECTS u 20 to date u Mean age 12.8 years (10-15 yrs) u 19 ASA I, 1 ASA II

44. PHYSIOLOGICAL STATUS u Mean Dose –Midazolam= 9.9mg ( 6.8-16mg) –Nitrous Oxide= 30% u Lowest O 2 saturation –Midazolam= mean 96.8% (range 95-99%) –Nitrous oxide= mean 97.9% (range 95-100%)

45. MEAN DURATION FOR SEDATION & TREATMENT u Time to Maximum Level of Sedation –Midazolam= mean 15.2 mins(8-20mins) –Nitrous oxide= mean 6.9 mins (2-10 mins) u Treatment time (La & ext) –Midazolam= mean 9.9 mins (6-16 mins) –Nitrous oxide= mean 7.7 mins (4-22 mins)

46. MEAN DURATION FOR RECOVERY & TOTAL APPOINTMENT u Time in recovery –Midazolam = mean 41.2 mins (28-64 mins) –Nitrous oxide = mean 21.5 mins (20-22 mins) u Total appointment time –Midazolam = mean 66.3 mins (60-90 mins) –Nitrous oxide = mean 34.1 mins (28-48 mins)

47. OVERALL BEHAVIOUR

48. POSITIVE RECALL OF STAGES OF APPOINTMENT

49. PATIENT QUESTIONNAIRES u 2 patients failed to return their post operative questionnaires. u The following results are based on 18 patients

50. PATIENT PREFERENCE u 66% would have Midazolam again u 89% would have Nitrous oxide again u 33% preferred Midazolam u 50% preferred Nitrous oxide u 17% had no preference

51. REASONS FOR PREFERENCE u Nitrous oxide/oxygen sedation –Quicker –Felt more relaxed –Recovered more quickly u Midazolam –Felt more relaxed –Remembered less

52. BEST ABOUT TREATMENT u Nitrous oxide/oxygen sedation –Quicker –Felt more relaxed –Nothing u Midazolam –Felt more relaxed –Quickness –Felt no pain

53. WORST ABOUT TREATMENT u Nitrous oxide/oxygen sedation –Being aware –Gums being frozen –Noises u Midazolam –Gums being frozen –Taste –Time for sedation to work

54. REPORTED SIDE EFFECTS u Nitrous oxide/oxygen sedation –Sleepy – 3 subjects –Headache – 1 subject u Midazolam –Sleepy – 3 subjects –Headache – 2 subjects

55. CONCLUSION u Promising results to date u Buccal midazolam appears to be an acceptable technique u The trial is on going u “Watch this space”

56. SUMMARY u Guidelines for conscious sedation u Current sedation techniques employed u Study of Benzodiazepines u Buccal midazolam trial

57. Intravenous ?Inhalation ? Transmucosal ? Oral ?