Download Procedure for the administration of oral

PROCEDURE FOR THE ADMINISTRATION
OF ORAL, BUCCAL OR INTRANASAL
MIDAZOLAM
FOR PREMEDICATION PRIOR TO DENTAL
CONSCIOUS SEDATION
Issue
History
Issue
Version
ONE
Purpose of Issue/Description of Change
Planned
Review Date
To promote safe and effective treatment for
adult patients who require premedication with
oral, buccal or intranasal midazolam.
2015
Named Responsible Officer:-
Approved by
Date
Clinical Director of Community
Dental Services
Quality, Patient Experience and
Risk Group
July 2013
Target Audience
Section:- Medicines Management
Salaried Dental Services
MMSOP41
UNLESS THIS VERSION HAS BEEN TAKEN DIRECTLY FROM TRUST WEB SITE THERE IS
NO ASSURANCE THIS IS THE CORRECT VERSION
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Procedure for the administration of oral, buccal or intranasal
midazolam for premedication prior to conscious sedation
To promote safe and effective treatment for adult patients who
require premedication with oral, buccal or intranasal midazolam
Quality and Governance Service (QGS)
Integrated into procedure
Yes No
Clinical Director of Community Dental Services
Andrew Kwasnicki Specialist in SCD Salaried Dental Services
Jackie Edwards Pharmacist
QGS
Medicines Management Group
June 2013
July 2013
Email
Date
Via QGS
VERSION CONTROL RECORD
Version Number
Author
Version 1
J Edwards
√
Status
N
Intranet
√
Location:- S Drive QGS
Changes / Comments
New procedure
Status – New / Revised / Trust Change
PROCEDURE FOR THE ADMINISTRATION
OF ORAL, BUCCAL OR INTRANASAL MIDAZOLAM
FOR PREMEDICATION PRIOR TO DENTAL CONSCIOUS SEDATION
2
PROCEDURE FOR THE ADMINISTRATION
OF ORAL, BUCCAL OR INTRANASAL MIDAZOLAM
FOR PREMEDICATION PRIOR TO DENTAL CONSCIOUS SEDATION
INTRODUCTION
This procedure outlines the actions to be followed by dentists who are qualified and required
to use premedication prior to conscious sedation for patients of Wirral Community NHS Trust
Salaried Dental Services (SDS).
This may take place within suitably equipped primary care dental surgeries or in the
secondary care setting of Arrowe Park Hospital Sedation Suite (APHSS).
It also outlines the actions to be followed by supporting Registered General Nurses (RGN) or
Sedation Trained Dental Care Professionals (STDCP) working within the dental sedation
team.
This procedure must be read in conjunction with MMSOP 21 for the administration of IV
midazolam for conscious sedation.
All staff involved must accept the following definition of conscious sedation:A technique in which the use of a drug or drugs, produces a state of depression of the central
nervous system enabling treatment to be carried out, but during which verbal contact with the
patient is maintained throughout the period of sedation. The drugs and techniques used to
provide conscious sedation for dental treatment should carry a margin of safety wide enough
to render loss of consciousness unlikely. The level of sedation must be such that the patient
remains conscious, retains protective reflexes and is able to understand and respond to
verbal commands. (General Dental Council GDC: “Maintaining Standards” 2001).
In patients who are unable to respond to verbal contact even when fully conscious (e.g.
patients with hearing impairment) the normal method of communicating with them must be
maintained. The concept of “deep sedation” in which the criteria listed above are not fulfilled is
regarded as general anaesthesia by the GDC.
TARGET GROUP
Suitably qualified and experienced Dental surgeons, Registered General Nurses and
Sedation Trained Dental Care Professionals working within the dental sedation team.
TRAINING
All staff in the Trust are required to comply with mandatory training, as specified in the Trust’s
Mandatory Training Matrix. Clinical Staff are also required to comply with service specific
mandatory training as specified within their service training matrix.
All dental clinicians undertaking premedication with oral, buccal or intranasal midazolam must
have successfully completed the training in conscious sedation as outlined in MMSOP 21: for
the administration of IV midazolam for conscious sedation. In addition all dental clinicians
should be suitably qualified in the premedication techniques outlined in this procedure and
PROCEDURE FOR THE ADMINISTRATION
OF ORAL, BUCCAL OR INTRANASAL MIDAZOLAM
FOR PREMEDICATION PRIOR TO DENTAL CONSCIOUS SEDATION
3
keep up to date continuous professional development records together with a portfolio of
evidence of the training experience and the techniques being used.
All STDCP or RGNs acting as the second appropriately trained person must have
successfully completed an appropriate training course as outlined in MMSOP 21 and have
relevant experience.
RELATED POLICIES
Please refer to relevant Trust policies and procedures.
INDICATIONS FOR PREMEDICATION PRIOR TO CONSCIOUS SEDATION
For a minority of patients who require conscious sedation for dental treatment it is not
possible to simply follow the SOP for IV midazolam. This is often because of an inability to
cope with the cannulation process due to either anxiety of this procedure or an inability to
understand or co-operate with this process. In these circumstances it is possible to provide a
form of premedication to facilitate/aid the cannulation process.
The type and choice of premedication is dependent on several factors including the patients’
tolerance to accepting the premedication, patient choice and the skills/ experience of the
operator.
The aim of premedication is not to reach the endpoints of conscious sedation (verrils sign
/eves sign), but to provide sufficient anxiolysis to allow cannulation to take place. In aiming for
anxiolysis rather than sedation it renders the likelihood of over sedation unlikely.
The three procedures outlined, use midazolam as either unlicensed products or for
unlicensed indications.
Oral administration: licensed product for an unlicensed indication.
Buccal administration: licensed or unlicensed product for an unlicensed indication
Intranasal administration: unlicensed product for an unlicensed indication
These techniques are recognised by the Standing Committee on Sedation for Dentistry in a
report Standards for Conscious Sedation in Dentistry: Alternative Techniques 2007
The procedures outlined within this document can only be given within the dental setting by
suitably qualified dental clinicians. They are not suitable for administration at home or by
patients or care staff.
The indications for conscious sedation are listed below:
•
Psychological / Social
•
Medical
•
Dental
Refer to MMSOP 21 for further details
PROCEDURE FOR THE ADMINISTRATION
OF ORAL, BUCCAL OR INTRANASAL MIDAZOLAM
FOR PREMEDICATION PRIOR TO DENTAL CONSCIOUS SEDATION
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ASSESSMENT OF PATIENTS
Assessment establishes the suitability of the patient to undergo premedication prior to
conscious sedation and is essential to the process of consent.
Patients should be assessed using the inclusion and exclusion criteria outlined in MMSOP 21.
ASSESSMENT VISIT
All patients who undergo premedication prior to conscious sedation must be assessed prior to
treatment and it is best practice for consent to be done at this assessment appointment. The
assessment is ideally performed within the clinical setting in which treatment is to take place.
This is in order to familiarise the patient/carer with the venue and surroundings. This
facilitates acclimatisation and gives the sedation team an opportunity to establish a rapport
with the anxious patient. However under certain circumstances it may be impractical to carry
out the assessment within the same setting (for example a patient with learning disabilities
who’s initial appointment is at an alternative clinic who would find it stressful and upsetting to
undergo a second assessment visit elsewhere.)
Please follow MMSOP21 for the full details required at the assessment visit.
Using this information and by referring to the inclusion and exclusion criteria, the suitability
and need of the patient to receive this treatment is established. If the patient fulfils the criteria
for premedication prior to conscious sedation within the SDS, a treatment plan is devised and
the consent process begins.
•
•
•
•
•
•
•
Pre and post-operative verbal and written instructions must be given to the patient/carer
regarding the premedication (including the use of licensed or unlicensed medicines for an
unlicensed indication) and conscious sedation by the dental clinician, this must then be
documented within the clinical notes. Patient information leaflets on pre and post-operative
instructions are available on the Trust intranet.
The role and the responsibilities of the appropriate escorting person must be explained
and highlighted to the patient/carer.
Patient information leaflets (PIL)s outlining the treatment to be performed must be
discussed verbally and given in writing. e.g. extraction / root canal. PILs outlining specific
treatments are available on the Trust intranet.
Record in the patient’s notes the issue and discussion of the PIL.
Full written consent must be gained for the treatment plan using Trust approved consent
forms.
Prior to administration of unlicensed medicines staff involved in administration should
ensure they have appropriate informed consent.
Document the phone number of the responsible adult escort to ring, if, after the procedure,
an emergency arises.
Once the process of consent is complete:• Convenient treatment appointments are arranged.
Prior to leaving the surgery a final check must be made that the patient is happy with the
proposed treatment plan and that they fully understand what their and the escorts
PROCEDURE FOR THE ADMINISTRATION
OF ORAL, BUCCAL OR INTRANASAL MIDAZOLAM
FOR PREMEDICATION PRIOR TO DENTAL CONSCIOUS SEDATION
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responsibilities are on the day of treatment. Further emphasis must be made for the need to
keep the appointments.
Consent although agreed at this appointment must be revisited at every sedation appointment
CONSENT
Valid consent must be given voluntarily by an appropriately informed person prior to any
procedure or intervention. No one can give consent on behalf of another adult who is deemed
to lack capacity regardless of whether the impairment is temporary or permanent. However
such patients can be treated if it is deemed to be within their best interest. This must be
recorded within the patient’s health records with a clear rationale stated at all times. Refer to
Trust Consent Policy for further information and guidance.
EQUIPMENT
It is the responsibility of the supporting RGN or STDCP to ensure that the surgery is fully
operational and all monitoring equipment is checked, regularly maintained, fully working and
appropriate records are kept.
•
The supporting RGN or STDCP is required to prepare the premedication tray and the
reversal tray (tray 2), the contents of which are outlined below.
• Batch numbers and expiry dates of medicines and instruments used must be logged,
ensuring that expiry dates have not been exceeded.
• These two medicine trays should be available at the chair side for every patient
receiving premedication with midazolam, (together with tray 1 for the conscious
sedation procedure as outlined in MMSOP 21)
• When not in use all medicines are to be locked away.
The premedication tray must contain the following:
Premedication Tray
Oral administration
The required number of
Midazolam 5mg in 5ml
ampoules
10ml syringe or 20ml
syringe, as required
Filter needle
Adhesive “midazolam 1mg
in 1ml label
Plastic cup
Buccal administration
The required number of dosage
units of Buccal midazolam 10mg
in 1ml, oromucosal solution
1ml syringe(s) (provided with
buccal midazolam)
Adhesive “buccal midazolam
10mg in 1ml” label(s)
Intranasal administration
Midazolam HCI 40mg/ml and
Lidocaine
HCI
20mg/ml
ampoule
1ml syringe
Filter needle
Adhesive “midazolam
40mg/ml, lidocaine 20mg/ml”
label
Mucosal atomisation device
PROCEDURE FOR THE ADMINISTRATION
OF ORAL, BUCCAL OR INTRANASAL MIDAZOLAM
FOR PREMEDICATION PRIOR TO DENTAL CONSCIOUS SEDATION
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Tray 2 must contain the following:
Tray 2 (Reversal Drug Tray)
Flumazenil (500mcg /5ml)
Adhesive “Flumazenil 500mcg/5ml” label
5ml syringe
Drawing up needle
The reversal drug tray (Tray 2) should be kept at the chair side, but in a location apart from
the midazolam drug trays.
The reversal agent Flumazenil should not be drawn up unless it is required to be administered
to the patient
Standard equipment
Single use disposable non sterile gloves
Single use disposable apron
Single use disposable visors/face masks & eye protection
Other standard equipment as in MMSOP21
TYPES OF PREMEDICATION
• Inhalation sedation (IHS) with nitrous oxide – added for completeness, but not referred to
in the remainder of this procedure.
• Oral midazolam
• Buccal Midazolam
• Intranasal midazolam.
CLERKING IN PROCEDURE
Refer to MMSOP 21for full details
PROCEDURE FOR PREMEDICATION PRIOR TO CONSCIOUS SEDATION
ACTION
The dental clinician must verbally confirm
the identity of the patient by asking for their
full name and date of birth. If the patient is
unable to confirm, check identity with
family/carer.
The dental clinician and RGN/STDCP must
introduce themselves and any other
colleagues involved at the contact, as staff
members.
The dental clinician and RGN/STDCP must
RATIONALE
To avoid mistaken identity.
To promote mutual respect and put patient
at their ease.
For patients to know who they are seeing
PROCEDURE FOR THE ADMINISTRATION
OF ORAL, BUCCAL OR INTRANASAL MIDAZOLAM
FOR PREMEDICATION PRIOR TO DENTAL CONSCIOUS SEDATION
7
wear identity badges which include name
status and designation.
The dental clinician must check procedures
have been completed to gain valid consent
including outlining the risks and benefits and
this must be documented in the patient’s
record.
Written consent must be obtained prior to
the administration of sedative drugs.
The dental clinician must establish that the
patient has no known allergies to the
medication being administered, checking in
the patient’s records and also by asking
patient/family of any known allergies.
The dental clinician must document any
known allergies.
Decontaminate hands prior to procedure
Apply personal protective equipment (PPE)
as outlined above.
and to promote mutual respect.
To ensure the patient understands the
procedure and relevant risks.
To comply with Trust policy.
To reduce risk of allergic reactions.
To reduce the risk of transfer of transient
micro-organisms on the healthcare worker’s
hands.
To protect clothing or uniform from
contamination and potential transfer of
micro-organisms and to protect hands from
contamination with organic matter and
transfer of micro-organisms.
IMPORTANT NOTE
For the subsequent dental conscious sedation procedure, the IV dose of midazolam will
need to be adjusted according to the patient’s response, which in turn is influenced by the
premedication dose of midazolam.
How to administer Midazolam orally for sedation purposes
Oral Midazolam for sedation
•
•
•
•
When considering the appropriate dose of Midazolam for premedication:
the usual oral dose of midazolam is 10mg
If the patient is small or elderly, and known to be highly sensitive to benzodiazepines
consider reducing the dose to 5mg
If the patient has previously had oral or IV midazolam and not been very susceptible
consider increasing the dose to a maximum of 20mg
The dentist must document the prescribed dose in the patient’s care plan
PROCEDURE FOR THE ADMINISTRATION
OF ORAL, BUCCAL OR INTRANASAL MIDAZOLAM
FOR PREMEDICATION PRIOR TO DENTAL CONSCIOUS SEDATION
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It is the responsibility of a suitably qualified person to draw up and administer this drug.
The volume must be checked by a separate suitably qualified person.
Check the batch number and expiry date of
the required number of ampoules (as
outlined in the care plan) checking that they
are midazolam 5mg in 5ml and record the
details in the patient’s notes.
Open the required number of ampoules of
Midazolam carefully.
Whilst supporting the midazolam 5mg in 5ml
ampoule, insert a 10ml or 20ml syringe as
appropriate and draw up the dose indicated
in the care plan using a filter needle. Label
the syringe “Midazolam 1mg in 1ml”
Remove the needle/nipple from the syringe
and discard.
Place the whole amount as outlined in the
care plan directly into, no more than 100ml
of, undiluted juice and label the cup
‘Midazolam xx mg (amount as indicated in
the care plan).
Ask the patient to drink the full amount from
the cup and gauge their response by clinical
and electromechanical monitoring.
Record the midazolam dosage and route
administered in the ‘Controlled drugs record
book’.
To maintain accurate records and ensure a
robust audit trail.
On completion of procedure remove and
dispose of PPE to comply with waste
management policy
Decontaminate hands following removal of
PPE
To prevent cross infection
and environmental contamination
To ensure health and safety and reduce the
risk of injury.
To ensure no fragments of glass are
administered to the patient
To ensure the
appropriate dose
patient
receives
the
To maintain accurate records and ensure a
robust audit trail.
To remove any accumulation of transient
and resident skin flora that may have built
up under gloves and possible contamination
following removal of PPE
PROCEDURE FOR THE ADMINISTRATION
OF ORAL, BUCCAL OR INTRANASAL MIDAZOLAM
FOR PREMEDICATION PRIOR TO DENTAL CONSCIOUS SEDATION
9
How to administer Midazolam buccally for sedation purposes.
•
•
•
•
When considering the appropriate dose of Midazolam for premedication:
the usual buccal dose of midazolam is 10mg
If the patient is small or elderly, and known to be highly sensitive to benzodiazepines
consider reducing the dose to 5mg
If the patient has previously had buccal or IV midazolam and not been very susceptible
consider increasing the dose to a maximum of 15 mg
The dentist must document the prescribed dose in the patient’s care plan
It is the responsibility of a suitably qualified person to draw up and administer this drug.
The volume must be checked by a separate suitably qualified person.
Check the batch number and expiry date of
the buccal midazolam, checking that it is
buccal midazolam 10mg in 1ml, oromucosal
solution and record the details in the
patient’s notes.
Use the 1ml syringe provided with buccal
midazolam.
Draw up the required amount, according to
the patient’s care plan, into the 1ml syringe.
To maintain accurate records and ensure a
robust audit trail.
To avoid wrong route errors
If administering 15mg, two 1ml syringes for
buccal administration are required one of which
will to be drawn up to 1ml and second to be
drawn up to 0.5ml
Label the syringe ‘buccal midazolam 10mg
in 1ml’.
If a second syringe is required label as 5mg
in 0.5ml
Deliver ½ the dose via syringe into the left
buccal sulcus.
Deliver ½ the dose via syringe into the right
buccal sulcus.
Record the midazolam dosage and route
administered in the ‘Controlled drugs record
book’.
To reduce the risk of medication errors.
On completion of procedure remove and
dispose of PPE to comply with waste
management policy
Decontaminate hands following removal of
PPE
To prevent cross infection
and environmental contamination
To maintain accurate records and ensure a
robust audit trail.
To remove any accumulation of transient
and resident skin flora that may have built
up under gloves and possible contamination
following removal of PPE
PROCEDURE FOR THE ADMINISTRATION
OF ORAL, BUCCAL OR INTRANASAL MIDAZOLAM
FOR PREMEDICATION PRIOR TO DENTAL CONSCIOUS SEDATION
10
How to administer Midazolam HCI 40mg/ml and Lidocaine HCI 20mg/ml intranasally
for sedation purposes.
Standard midazolam dose 10mg
For a patient who:
• is small or elderly, and known to be highly sensitive to benzodiazepines consider
reducing the dose to 5mg,
• has previously had oral or IV midazolam and not been very susceptible consider
increasing the dose to the maximum 15mg
• The dentist must document the prescribed dose of midazolam in the patient’s care
plan.
It is the responsibility of the Dentist to draw up and administer this drug.
The volume must be checked by a suitably qualified person.
Inspect the nostrils for significant amounts
Significant mucosal discharge or blood
of mucous discharge or blood
could alter the absorption of the midazolam.
Consider alternative route of administration
if the nostrils are blocked
Proceed if the nostril are not blocked
Check the batch number and expiry date of To maintain accurate records and ensure a
the ampoule and record the details in the
robust audit trail.
patient’s notes. Check that the ampoule is
To check the ampoules are in date and the
labelled “Midazolam HCI 40mg/ml and
correct product has been selected.
Lidocaine HCl 20mg/ml”
Open the ampoule carefully.
To ensure health and safety and reduce the
risk of injury.
Whilst supporting the ampoule, insert a 1ml To ensure no fragments of glass are
syringe with filter needle attached and draw administered to the patient.
up the amount in the care plan plus the
volume of the dead space in the intranasal
atomising device
For example:
For a 10mg if the dead space is 0.1ml draw up
0.1ml+0.25ml = 0.35ml
Label the syringe ‘Midazolam 40mg/ml,
To reduce the risk of medication errors.
Lidocaine 20mg/ml’.
Remove the needle from the syringe and
To prevent inoculation injury.
safely dispose of into an appropriate sharps
container.
Ask the patient to be seated in the dental
chair and ask them to rest their head back.
Support the head and chin, therefore
supporting the head.
Place the mucosal atomisation device on
the end of the syringe and place this into the
PROCEDURE FOR THE ADMINISTRATION
OF ORAL, BUCCAL OR INTRANASAL MIDAZOLAM
FOR PREMEDICATION PRIOR TO DENTAL CONSCIOUS SEDATION
11
patient’s nostril.
Instruct the patient to sniff as you push the
plunger of the syringe.
Record the midazolam dosage and route
administered in the ‘Controlled drugs record
book’.
On completion of procedure remove and
dispose of PPE to comply with waste
management policy
Decontaminate hands following removal of
PPE
To maintain accurate records and ensure a
robust audit trail.
To prevent cross infection
and environmental contamination
To remove any accumulation of transient and
resident skin flora that may have built up
under gloves and possible contamination
following removal of PPE
PROCEDURE TO BE FOLLOWED IN THE EVENT OF OVER SEDATION
ACTION
RATIONALE
Flumazenil should always be available and
stored in a separate tray. It should be used
to reverse the effects of midazolam if
required. The availability of this reversal
agent does not justify poor titration
technique or over dosage with midazolam.
The recommended initial dose is 200
micrograms (2ml) administered
intravenously over 15 seconds
If the desired level of consciousness is not
obtained within 60 seconds a further dose of
100 micrograms (1ml) can be injected and
repeated if necessary at 60 second intervals
up to a maximum total dose of 1mg (10ml)
Document all details of medication
administered, including dosage and route of
administration.
In the event of flumazenil being
administered, it is essential that the patient’s
escort is informed. This is because the half
– life of flumazenil is shorter than
midazolam and there is the possibility of resedation occurring.
A Trust incident form must be completed
If there is a need to administer Flumazenil,
administration must be recorded in the
patient’s notes and in the log book within
the surgery to be audited on a yearly basis
If flumazenil is required, it must always be
drawn up into a 5ml syringe and the
clinician should inform the second
appropriate person that they are about to
administer flumazenil.
To follow manufacturer’s instructions
To comply with the recommendations made
by the National Patient Safety Alert RRR011
(2008) Reducing the risk of overdose with
midazolam injection in adults to promote
patient safety
To maintain accurate records
To promote patient safety
To maintain a robust audit trail
PROCEDURE FOR THE ADMINISTRATION
OF ORAL, BUCCAL OR INTRANASAL MIDAZOLAM
FOR PREMEDICATION PRIOR TO DENTAL CONSCIOUS SEDATION
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DETERIORATING PATIENTS
Should a patient deteriorate the Trust Deteriorating Patient Policy must be followed and an
SBAR (Situation, background, assessment and recommendations) completed when referring
patient to emergency services and all treatment given recorded in the patient’s health records.
INCIDENT REPORTING
Clinical incidents or near misses must be reported via the Trust’s incident reporting system.
SAFEGUARDING
In any situation where staff may consider the patient to be a vulnerable adult, they need to
follow the Trust Safeguarding Adult Policy and discuss with their line manager and document
outcomes.
EQUALITY ASSESSMENT
During the development of this protocol the Trust has considered the clinical needs of
each protected characteristic (age, disability, gender, gender reassignment, pregnancy and
maternity, race, religion or belief and sexual orientation). There is no evidence of exclusion of
these named groups.
If staff become aware of any clinical exclusions that impact on the delivery of care a Trust
Incident form would need to be completed and an appropriate action plan put in place.
REFERRALS
Any referrals to health professionals, therapists or other specialist services must be followed
up and all professional advice or guidance documented in the patients health records
REFERENCES
Scottish Dental Clinical Effectiveness Programme. Conscious Sedation in Dentistry Dental
Clinical Guidance.. June 2012.
Standards for Conscious Sedation in Dentistry: Alternative Techniques
A Report from the Standing Committee on Sedation for Dentistry 2007
NPSA/2008/RRR011 Reducing risk of overdose with midazolam injection in adults.
BNFfor children. 2012-13
M. C. G. Manley, N. J. Ransford, D. A. Lewis, S. A. Thompson and M. Forbes. Retrospective
audit of the efficacy and safety of the combined intranasal/intravenous midazolam sedation
PROCEDURE FOR THE ADMINISTRATION
OF ORAL, BUCCAL OR INTRANASAL MIDAZOLAM
FOR PREMEDICATION PRIOR TO DENTAL CONSCIOUS SEDATION
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technique for the dental treatment of adults with learning disability. British Dental Journal
2008; 205: E3
APPENDICIES
Appendix 1
American Society of Anaesthesiology Classification of Physical Status
ASA Classification
Class
1
2
3
4
5
Patient Condition
A normal healthy patient
A patient with mild systemic disease
A patient with severe systemic disease
A patient with severe systemic
disease that is a constant
threat to life
A moribund patient who is not
expected to survive without the
operation
PROCEDURE FOR THE ADMINISTRATION
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FOR PREMEDICATION PRIOR TO DENTAL CONSCIOUS SEDATION
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