Transcript AN AUDIT OF THE USE OF ORAL MIDAZOLAM SEDATION IN THE

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
 Guidelines
 Current
for conscious sedation
sedation techniques
 Benzodiazepine
 Current
sedation
research
Need for Sedation
“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
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

“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
 May
exposure to nitrous oxide
not be accepted by some patients
Current Sedation Practice
A
need to consider other forms of sedation
 Benzodiazepines
 Limited
have favourable pharmacology
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
 Most
favourable pharmacology of BZDs
 Used
extensively in adults via the IV route
 Limited
 May
use in those under 16 years
provide an alternative where inhalation
sedation contraindicated
Midazolam – clinical effects
 Anxiolysis
 Sedation
 Muscle
relaxation
 Amnesia
Midazolam – side effects
 Respiratory
depression
 Drug
interactions
– CNS depressants
– Antibiotics
– Antacids
 Tolerance
 Dis-inhibition
Advantages
 Can
be titrated (IV route)
 Potent
anxiolytic effect
 Amnesia
 Muscle
relaxation
Disadvantages
 May
require IV cannulation
 Length
 Side
of appointment time
effects (minimal)
 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
 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
 Produced
formulation – 10mg/ml
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
ASSESSMENT CRITERIA
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 & awake
2 – awake & calm
3 – tired, hardly moving
4 – drowsy, without reaction but rousable
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
OUTCOME OF TREATEMTENT
& OVERALL BEHAVIOUR
 “Houpt
Behaviour Rating Scale”

Recorded at end of visit

Six point scale:
1 – Aborted
2 – Poor
3 – Fair
4 – Good
5 – Very good
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?
RESULTS
SUBJECTS
 20
to date
 Mean
 19
age 12.8 years (10-15 yrs)
ASA I, 1 ASA II
PHYSIOLOGICAL STATUS
 Mean
Dose
– Midazolam
– Nitrous Oxide
 Lowest
= 9.9mg ( 6.8-16mg)
= 30%
O2 saturation
– Midazolam
– Nitrous oxide
= mean 96.8% (range 95-99%)
= mean 97.9% (range 95-100%)
MEAN DURATION FOR
SEDATION & TREATMENT
 Time
to Maximum Level of Sedation
– Midazolam
– Nitrous oxide
 Treatment
= mean 15.2 mins(8-20mins)
= mean 6.9 mins (2-10 mins)
time (La & ext)
– Midazolam
– Nitrous oxide
= mean 9.9 mins (6-16 mins)
= mean 7.7 mins (4-22 mins)
MEAN DURATION FOR
RECOVERY & TOTAL APPOINTMENT
 Time
in recovery
– Midazolam
– Nitrous oxide
 Total
= mean 41.2 mins (28-64 mins)
= mean 21.5 mins (20-22 mins)
appointment time
– Midazolam
– Nitrous oxide
= mean 66.3 mins (60-90 mins)
= mean 34.1 mins (28-48 mins)
OVERALL BEHAVIOUR
No of
Subjects
18
16
14
12
10
8
6
4
2
0
Midazolam
Nitrous oxide
Excellent
Very Good
Good
Fair
Poor
Overall Behaviour Score
Aborted
POSITIVE RECALL OF
STAGES OF APPOINTMENT
20
18
16
14
12
No of
Subjects 10
8
6
4
2
0
Midazolam
Nitrous oxide
Local
Anaesthetic
Extraction
Recovery
Stage of Appointment
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
 Current
 Study
for conscious sedation
sedation techniques employed
of Benzodiazepines
 Buccal
midazolam trial
Intravenous ?
Inhalation ?
Transmucosal ?
Oral ?