Benzodiazepines: A novel

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Benzodiazepines A novel route to sedation for
the anxious adolescentKathy WilsonSenior
Dental Officer Honorary Staff GradeSouth
Tyneside PCT Newcastle Dental School

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

• Guidelines for conscious sedation
• Current sedation techniques
• Benzodiazepine sedation
• Current research

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Need for Sedation
The control of pain anxiety is an integral
part of dental practice. General Dental
Council 2001
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Need for Sedation
LA, supplemented where necessary by simple
sedation, should be first choice for pain
anxiety control Faculty of GDPs 1998
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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
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Current Guidelines

• A Conscious Decision
• DOH 2000
• Maintaining Standards
• GDC 2001
• Safe Sedation of Children undergoing Diagnostic
  and Therapeutic procedures
• Conscious Sedation in the Provision of Dental
  Care
• SDAC 2003

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A Conscious Decision

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

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Maintaining Standards

• A dentist who assumes the dual responsibility of
  sedating the patient as well as providing
  treatment must
• be able to justify the use of the method
  selected with reference to current guidelines
• GDC Maintaining Standards Nov 2001

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SIGN Guidelines

• Safe Sedation of Children Undergoing Diagnostic
  and Therapeutic Procedures A national clinical
  guideline
• Relates to those under age of 16 years
• Published in Feb 2002
• www.sign.ac.uk

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Main Recommendations Dental Sedation

• Nitrous oxide/oxygen inhalation sedation
• is recommended for use in all dental settings
  but particularly General Dental Practice and
  Community Dental Service

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Main Recommendations Dental Sedation

• 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.

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Main Recommendations Dental Sedation

• 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

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Conscious Sedation in the provision of Dental
care

• Aim
• To lay down specific guidance for the practice
  of Conscious Sedation in general dental practice,
  community and hospital settings
• SDAC 2003

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Main Recommendations for sedation in adolescents

• Must only be undertaken by teams which have
  adequate training and experience
• Nitrous oxide/oxygen should be first choice

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Main Recommendations for sedation in adolescents

• IV sedation only appropriate in a minority of
  cases
• Oral/Intranasal/Transmucosal sedation should only
  be administered under appropriate circumstances
  by a practitioner experienced in their use

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Current Sedation Practice

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

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Current Sedation Practice

• A need to consider other forms of sedation
• Benzodiazepines have favourable pharmacology
• Limited research into the use of midazolam in
  dental patients under the age of 16 in UK

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A study of the use of Benzodiazepines in
adolescent dental patients
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Midazolam

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

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Midazolam clinical effects

• Anxiolysis
• Sedation
• Muscle relaxation
• Amnesia

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Midazolam side effects

• Respiratory depression
• Drug interactions
• CNS depressants
• Antibiotics
• Antacids
• Tolerance
• Dis-inhibition

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Advantages

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

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Disadvantages

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

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Intravenous ?
Inhalation ?
?
Transmucosal ?
Oral ?
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A STUDY OF THE EFFECTIVENESS OF BUCCAL MIDAZOLAM
SEDATION FOR ORTHODONTIC EXTRACTIONS
Dr K E Wilson University of Newcastle upon Tyne
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Aim of Research Project

• Effectiveness and acceptability of midazolam for
  dental extractions in adolescent patients
• Different routes researched
• Oral (Anaesthesia 2002 57 860-867)
• Intravenous (British Journal of Anaesthesia 2003
  Dec)
• Transmucosal

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Transmucosal Sedation

• Routes
• Sublingual
• Intranasal
• Buccal
• Rectal (not in UK)
• Advantages
• Rapid absorption
• Avoids 1st pass metabolism
• Disadvantages
• Taste
• Irritation of tissues

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Buccal Midazolam

• Concentrated formulation 10mg/ml
• Produced by Special Products
• Formulated for use in Epileptic Patients

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METHOD

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

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METHOD

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

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BUCCAL MIDAZOLAM SEDATION

• Buccal midazolam (0.2mg/kg) 10-15 minutes pre-op
• Monitored by sedation trained Dental Nurse
• Treatment carried out (LA Extractions)
• Recovery
• Discharged when fit

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NITROUS OXIDE SEDATION

• Nitrous oxide titrated 10 every minute
• (max 30)
• Treatment carried out (LA Extractions)
• Recovery
• Discharged when fit

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ASSESSMENT CRITERIA
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PHYSIOLOGICAL STATUS

• Baseline
• BP, Pulse, Weight, Respiratory Rate,
• Oxygen Saturation
• Every 2 minutes
• Pulse, Respiratory Rate, Oxygen Saturation

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LEVEL OF SEDATION

• Classification of Emotional Status
  (Brietkopf Buttner)
• Recorded every 2 minutes
• Four point scale
• 1 irritated awake
• 2 awake calm
• 3 tired, hardly moving
• 4 drowsy, without reaction but rousable

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BEHAVIOUR DURING TREATMENT

• Frankl Behaviour Rating Scale
• Recorded every 2 minutes
• Four point scale
• 1 Refusal / Distress
• 2 Uncooperative / Reluctant
• 3 Cooperative / Reserved
• 4 Interested / Enjoyed

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OUTCOME OF TREATEMTENT OVERALL BEHAVIOUR

• Houpt Behaviour Rating Scale
• Recorded at end of visit
• Six point scale
• 1 Aborted 4 Good
• 2 Poor 5 Very good
• 3 Fair 6 Excellent
  

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POST-OPERATIVELY

• Post-operative Questionnaire
• Recall of treatment
• Same sedation again
• Preference for sedation
• Side effects

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RECALL OF TREATMENT

• Patients were asked if they could remember
• Receiving the local anaesthetic
• Having the extractions carried out
• Being in recovery

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PATIENTS OPINION OF TREATMENT

• Patients were asked
• Would you have this sedation again?
• Which type of sedation did you prefer?

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RESULTS
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SUBJECTS

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

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PHYSIOLOGICAL STATUS

• Mean Dose
• Midazolam 9.9mg ( 6.8-16mg)
• Nitrous Oxide 30
• Lowest O2 saturation
• Midazolam mean 96.8 (range 95-99)
• Nitrous oxide mean 97.9 (range 95-100)

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MEAN DURATION FOR SEDATION TREATMENT

• Time to Maximum Level of Sedation
• Midazolam mean 15.2 mins(8-20mins)
• Nitrous oxide mean 6.9 mins (2-10 mins)
• Treatment time (La ext)
• Midazolam mean 9.9 mins (6-16 mins)
• Nitrous oxide mean 7.7 mins (4-22 mins)

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MEAN DURATION FOR RECOVERY TOTAL APPOINTMENT

• Time in recovery
• Midazolam mean 41.2 mins (28-64 mins)
• Nitrous oxide mean 21.5 mins (20-22 mins)
• Total appointment time
• Midazolam mean 66.3 mins (60-90 mins)
• Nitrous oxide mean 34.1 mins (28-48 mins)

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OVERALL BEHAVIOUR
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POSITIVE RECALL OF STAGES OF APPOINTMENT
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PATIENT QUESTIONNAIRES

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

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PATIENT PREFERENCE

• 66 would have Midazolam again
• 89 would have Nitrous oxide again
• 33 preferred Midazolam
• 50 preferred Nitrous oxide
• 17 had no preference

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REASONS FOR PREFERENCE

• Nitrous oxide/oxygen sedation
• Quicker
• Felt more relaxed
• Recovered more quickly
• Midazolam
• Felt more relaxed
• Remembered less

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BEST ABOUT TREATMENT

• Nitrous oxide/oxygen sedation
• Quicker
• Felt more relaxed
• Nothing
• Midazolam
• Felt more relaxed
• Quickness
• Felt no pain

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WORST ABOUT TREATMENT

• Nitrous oxide/oxygen sedation
• Being aware
• Gums being frozen
• Noises
• Midazolam
• Gums being frozen
• Taste
• Time for sedation to work

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REPORTED SIDE EFFECTS

• Nitrous oxide/oxygen sedation
• Sleepy 3 subjects
• Headache 1 subject
• Midazolam
• Sleepy 3 subjects
• Headache 2 subjects

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CONCLUSION

• Promising results to date
• Buccal midazolam appears to be an acceptable
  technique
• The trial is on going
• Watch this space

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SUMMARY

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

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Intravenous ?
Inhalation ?
?
Transmucosal ?
Oral ?