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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 CONTROL RECORD Title Purpose Author Equality Assessment Subject Experts Document Librarian Groups consulted with :Infection Control Approved Date formally approved by Quality, Patient Experience and Risk Group Method of distribution Archived Access 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 4 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 5 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 6 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 8 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 12 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 13 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 OF ORAL, BUCCAL OR INTRANASAL MIDAZOLAM FOR PREMEDICATION PRIOR TO DENTAL CONSCIOUS SEDATION 14