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

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 use in those under 16 years

May 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 of appointment time

Side 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 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

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 & 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?

RESULTS

SUBJECTS

20 to date

Mean age 12.8 years (10-15 yrs)

19 ASA I, 1 ASA II

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

Intravenous ? Inhalation ?

Transmucosal ?Oral ?