Benzodiazepines: A novel “route” to sedation for the anxious adolescent
Kathy Wilson
Senior Dental Officer & Honorary Staff GradeSouth 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
Guidelines for conscious sedation
Current sedation techniques
Benzodiazepine sedation
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 forpain & 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 outbut during which
verbal contact with the patient is maintained throughout the period of treatment”
General Dental Council 2001
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
“A Conscious Decision”
“A Conscious Decision” DOH 2000
Emphasises the need to provide alternatives to GA for pain and anxiety management.
“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
“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
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”
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.”
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…”
“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
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
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
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
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
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
Midazolam – side effects
Respiratory depression
Drug interactions– CNS depressants– Antibiotics – Antacids
Tolerance
Dis-inhibition
Disadvantages
May require IV cannulation
Length of appointment time
Side effects (minimal)
Dis-inhibition
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
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
Transmucosal Sedation Routes
– Sublingual– Intranasal– Buccal– Rectal (not in UK)
Advantages– Rapid absorption– Avoids 1st pass metabolism
Disadvantages– Taste – Irritation of tissues
Buccal Midazolam
Concentrated formulation – 10mg/ml
Produced by Special Products
Formulated for use in Epileptic Patients
METHOD
Prospective, randomised, crossover trial
40 patients, aged 10 to 16 years, ASA I & II
Referred for orthodontic extractions
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
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
NITROUS OXIDE SEDATION
Nitrous oxide titrated 10% every minute (max 30%)
Treatment carried out (LA & Extractions)
Recovery
Discharged when fit
PHYSIOLOGICAL STATUS
Baseline
– BP, Pulse, Weight, Respiratory Rate, Oxygen Saturation
Every 2 minutes
– Pulse, Respiratory Rate, Oxygen Saturation
LEVEL OF SEDATION “Classification of Emotional Status”
(Brietkopf & Buttner)
Recorded every 2 minutes
Four point scale
1 – irritated & awake2 – awake & calm3 – tired, hardly moving4 – drowsy, without reaction but rousable
BEHAVIOUR DURING TREATMENT
“Frankl Behaviour Rating Scale”
Recorded every 2 minutes
Four point scale:
1 – Refusal / Distress2 – Uncooperative / Reluctant3 – Cooperative / Reserved4 – Interested / Enjoyed
OUTCOME OF TREATEMTENT & OVERALL BEHAVIOUR
“Houpt Behaviour Rating Scale”
Recorded at end of visit
Six point scale:
1 – Aborted 4 – Good2 – 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
Patients were asked if they could remember:
– Receiving the local anaesthetic
– Having the extractions carried out
– Being in recovery
PATIENT’S OPINION OF TREATMENT
Patients were asked:
– Would you have this sedation again?
– Which type of sedation did you prefer?
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%)
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)
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)
OVERALL BEHAVIOUR
0
2
4
6
8
10
12
14
16
18
No of Subjects
Excellent Very Good Good Fair Poor Aborted
Overall Behaviour Score
Midazolam
Nitrous oxide
POSITIVE RECALL OF STAGES OF APPOINTMENT
02468
101214161820
No of Subjects
LocalAnaesthetic
Extraction Recovery
Stage of Appointment
Midazolam
Nitrous oxide
PATIENT QUESTIONNAIRES
2 patients failed to return their post operative questionnaires.
The following results are based on 18 patients
PATIENT PREFERENCE
66% would have Midazolam again
89% would have Nitrous oxide again
33% preferred Midazolam 50% preferred Nitrous oxide 17% had no preference
REASONS FOR PREFERENCE
Nitrous oxide/oxygen sedation– Quicker– Felt more relaxed– Recovered more quickly
Midazolam– Felt more relaxed– Remembered less
BEST ABOUT TREATMENT
Nitrous oxide/oxygen sedation– Quicker– Felt more relaxed– Nothing
Midazolam– Felt more relaxed– Quickness– Felt no pain
WORST ABOUT TREATMENT
Nitrous oxide/oxygen sedation– Being aware– Gums being frozen– Noises
Midazolam– Gums being frozen– Taste– Time for sedation to work
REPORTED SIDE EFFECTS
Nitrous oxide/oxygen sedation– Sleepy – 3 subjects– Headache – 1 subject
Midazolam– Sleepy – 3 subjects– Headache – 2 subjects
CONCLUSION
Promising results to date
Buccal midazolam appears to be an acceptable technique
The trial is on going
“Watch this space”
SUMMARY
Guidelines for conscious sedation
Current sedation techniques employed
Study of Benzodiazepines
Buccal midazolam trial