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

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

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

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

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

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

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

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

“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

“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

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”

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.”

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…”

“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

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

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

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

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

A study of the use of Benzodiazepines in adolescent dental patients

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

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

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

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

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

Intravenous ?Inhalation ? Transmucosal ? Oral ?

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

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

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

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

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

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

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

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

ASSESSMENT CRITERIA

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

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

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

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

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

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

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

RESULTS

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

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

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)

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)

OVERALL BEHAVIOUR

POSITIVE RECALL OF STAGES OF APPOINTMENT

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

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

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

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

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

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

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”

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

Intravenous ?Inhalation ? Transmucosal ? Oral ?