WAHT-PAE-067 This guideline has been printed from the Worcestershire Acute Hospitals NHS Trust intranet on 19/10/2022,02:41 It is the responsibility of every individual to check that this is the latest version/copy of this document GUIDELINE FOR DOCTORS, NURSES AND PARENTS/CARERS ON THE USE OF BUCCAL MIDAZOLAM FOR PROLONGED SEIZURES IN CHILDREN This guidance does not override the individual responsibility of health professionals to make appropriate decision according to the circumstances of the individual patient in consultation with the patient and /or carer Health care professionals must be prepared to justify any deviation from this guidance INTRODUCTION The majority of children who have epilepsy usually recover within a short period of time after a seizure However there are occasions when the child goes into a prolonged seizure and occasionally “status epilepticus” A child who has experienced a prolonged seizure or status epilepticus may be prescribed Buccal Midazolam, by their doctor, in order to treat further prolonged seizures or serial seizures without recovery in between This guideline aims to establish a system for the prescription of Buccal Midazolam to be administered within the home environment, and to provide parents and carers with the information and training in the management of acute seizures and the indication of when and how to administer Midazolam via the Buccal route Note: Children are defined as persons under the age of 16 THIS GUIDELINE IS FOR USE BY THE FOLLOWING STAFF GROUPS : Medical staff and nurses Lead Clinician(s) Sharon Dawe Dr M Hanlon Epilepsy Specialist Nurse Children and Young People Consultant Paediatrician Approved by Paediatric Clinical Improvement Group: 19 September 2007 Medicines Safety Committee: This guideline should not be used after end of: 25 September 2007 September 2012 Key amendments to this guideline Date 17/08/10 17/08/10 17/08/10 05/10/10 16/12/10 Amendment Reference inserted – ‘McMullan J, SassonC, Pancioli A, ilbergleit R.Midazolam versus diazepam for the treatment of status epilepticus in children and young adults; a meta-analysis Dept of emergency Medicine University of Cincinnati June 17th 2010 [6];575-82’ Appendix one updated to include most recent epilepsy plan Grammar updated throughout document – guidance remains the same Slight amendment made to page format Minor amendments agreed at Paediatric CG meeting © Worcestershire Acute Hospital NHS Trust Guideline for doctors, nurses and parents/carers on the use of Buccal Midazolam in children By: Sharon Dawe Sharon Dawe Sharon Dawe Sharon Dawe Sharon Dawe Page of 12 WAHT-PAE-067 This guideline has been printed from the Worcestershire Acute Hospitals NHS Trust intranet on 19/10/2022,02:41 It is the responsibility of every individual to check that this is the latest version/copy of this document GUIDELINE FOR DOCTORS, NURSES AND PARENTS/CARERS ON THE USE OF BUCCAL MIDAZOLAM FOR PROLONGED SEIZURES IN CHILDREN INTRODUCTION WHY DO WE ADMINISTER BUCCAL MIDAZOLAM? The majority of children who have epilepsy usually recover within a short period of time after a seizure However there are occasions when this does not happen and the child goes into a prolonged seizure and occasionally “status epilepticus” The definition for a prolonged seizure will vary between individuals A child who has experienced a prolonged seizure or status epilepticus may be prescribed buccal midazolam, by their doctor, in order to treat further prolonged seizures or serial seizures without recovery in between THE AIM To ensure that children and young people are prescribed buccal midazolam where appropriate To ensure that staff and/or parents are familiar with buccal midazolam and its administration To preserve the privacy and dignity of children when administering medication wherever possible THE OBJECTIVE To establish a system for the prescription of buccal midazolam to be administered within the home environment [Appendix 1] To establish a system of documentation for the administration of buccal midazolam [Appendix 2] To provide parents and carers with the information and training in the management of acute seizures and the indication of when and how to administer buccal midazolam [Appendix 3] Definition children Children are defined as persons under the age of 16 unless under the care of a paediatrician © Worcestershire Acute Hospital NHS Trust Guideline for doctors, nurses and parents/carers on the use of Buccal Midazolam in children Page of 12 WAHT-PAE-067 This guideline has been printed from the Worcestershire Acute Hospitals NHS Trust intranet on 19/10/2022,02:41 It is the responsibility of every individual to check that this is the latest version/copy of this document GUIDELINE MIDAZOLAM Midazolam is a medication from the group of drugs called benzodiazepines that affect the central nervous system Midazolam has muscle relaxant and anti-convulsant properties Midazolam is commonly used for sedation of children for medical procedures The buccal preparation however is not licensed for use for seizures but studies have shown it is just as safe and effective as rectal diazepam DIFFERENT PREPARATIONS OF MIDAZOLAM A) Injection [as hydrochloride] 10 mgs in mls and 10mgs in mls ampoules [hypnovel] B) Syrup 2.5 mgs in ml C) Buccal midazolam [EPISTATUS] 10MGS in 1ml This is the product that will be prescribed for carers in the community to give SIDE EFFECTS ALL MEDICATION HAS THE POTENTIAL TO CAUSE SIDE EFFECTS.THE SIDE EFFECTS OF MIDAZOLAM MAY INCLUDE SHALLOW BREATHING [RESPIRATORY DEPRESSION] AND HALLUCINATIONS [RARE] • How your child will react to the medication is difficult to describe until the first time midazolam is given • With some sedation the ending of a seizure is expected within a few minutes • Flushing of the skin or a rash of pink spots can occur which disappear within 15 minutes • Contraindications are severe chest infection or asthma attack • In the community area a second dose should not be given by the carer within hours of receiving Midazolam unless authorised by the Consultant looking after the child] or related drug because of risk of respiratory depression [This rule does not apply to STATUS EPILEPTICUS when a second dose of rescue medication can be given after 10 mins by a paramedic who has the equipment to deal with respiratory depression, or medical personnel in hospital, as per protocol for STATUS.] The buccal route of administration for midazolam means that a small amount of the medication is given into the side of the mouth, by the back teeth of the lower jaw, between the gum and cheek area The midazolam is directly absorbed into the blood stream from this area and does not have to be swallowed This is a more convenient and more dignified route of administration © Worcestershire Acute Hospital NHS Trust Guideline for doctors, nurses and parents/carers on the use of Buccal Midazolam in children Page of 12 WAHT-PAE-067 This guideline has been printed from the Worcestershire Acute Hospitals NHS Trust intranet on 19/10/2022,02:41 It is the responsibility of every individual to check that this is the latest version/copy of this document As the indications when to administer medication and dosage will vary for each child, an individual prescription form is required The child’s Consultant will complete this and should be reviewed annually The prescription form (appendix 1) should clearly state: • The preparation, strength, dosage, and amount of the medication to be given • When the Midazolam is to be given e.g after minutes Included on the prescription form should be an indication of when an ambulance should be summoned • Guidance for age related doses of buccal midazolam [please always refer to BNF for children] For simplicity, the following regime can also be followed AGE OF CHILD Birth to months DOSE OF BUCCAL MIDAZOLAM 0.30mgs/kg 6-12 months 2.5mgs [ 0.25ml ] 1-4 years 5mgs [ 0.5ml ] 5-9 years 7.5mgs [ 0.75ml ] 10 years and over 10mgs [ ml ] PROVISION OF TRAINING TO PARENTS The medical staff will be responsible for teaching parents about the use of buccal midazolam for their child and again the teaching will include: • Ability to recognise and manage prolonged seizures including basic first aid • Familiarisation with the formulation of midazolam and ability to draw up the prescribed dose, which will be a very small volume, accurately • Familiarisation with the buccal route of administration • Knowledge of how to call a paramedic ambulance and the correct information to give when making an emergency call • Knowledge of how to record the administration of midazolam and the child’s response • All of the above are explained in appendices 1, 2, © Worcestershire Acute Hospital NHS Trust Guideline for doctors, nurses and parents/carers on the use of Buccal Midazolam in children Page of 12 WAHT-PAE-067 This guideline has been printed from the Worcestershire Acute Hospitals NHS Trust intranet on 19/10/2022,02:41 It is the responsibility of every individual to check that this is the latest version/copy of this document MONITORING TOOL Audit and monitoring of this policy For this policy there will be a system of monitoring its safety and effectiveness Records of midazolam administration will be collected by Sharon Dawe Epilepsy Specialist Nurse and monitored by a named Consultant Paediatrician (Dr M Hanlon) Audit results will be used to amend and update future versions of this policy STANDARDS Doses of buccal midazolam correct and given in line with the child’s individual advice and instruction given by the Consultant Any adverse events to be investigated % 100% Clinical Exceptions None 100% None How will monitoring be carried out? Parents to return forms to Consultant or Epilepsy Specialist Nurse Annually Also when attending OPA parents will be asked if they remain happy with the administration of the medication Dr M Hanlon and Sharon Dawe[ ESN] When seizures are well controlled with anti convulsants and all parties are in agreement a decision will be made not to prescribe further rescue medication For example; if the child has not had a prolonged seizure for the past 12 months When will monitoring be carried out? Who will monitor compliance with the guideline? Cancellation of prescription REFERENCE Royal College of Paediatrics and Child Health Medicines for Children 2003 Midazolam – listed alphabetically in Formulary Mahmoudian T Zadeh MM Comparison of intranasal midazolam with intravenous diazepam for treating acute seizures in children Epilepsy & Behavior 5(2):253-5, 2004 Apr Kutlu NO Dogrul M Yakinci C Soylu H Buccal midazolam for treatment of prolonged seizures in children Brain & Development 25(4):275-8, 2003 Jun Scott RC, Besag FMC, Neville BGR Buccal midazolam and rectal diazepam for treatment of prolonged seizures in childhood and adolescence Lancet 1999;353:623–6 Chattopadhyay A,Morris B, Blackburn,Wassmer E, Whitehouse W Buccal midazolam use in children Lancet 1999;353:1798 Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial McIntyre J, Robertson S, Norris E, Appleton R, Whitehouse WP, Phillips B, Martland T, Berry K, Collier J, Smith S, Choonara I Lancet 2005; 366:205-210 Paediatric Neurology Forum 26.02.07 McMullan J, SassonC, Pancioli A, ilbergleit R.Midazolam versus diazepam for the treatment of status epilepticus in children and young adults; a meta-analysis Dept of emergency Medicine University of Cincinnati June 17th 2010 [6]; 575-82 © Worcestershire Acute Hospital NHS Trust Guideline for doctors, nurses and parents/carers on the use of Buccal Midazolam in children Page of 12 WAHT-PAE-067 This guideline has been printed from the Worcestershire Acute Hospitals NHS Trust intranet on 19/10/2022,02:41 It is the responsibility of every individual to check that this is the latest version/copy of this document Appendix 1: See Document Management System for printable version EPILEPSY EMERGENCY MEDICATION PLAN Child’s name _ Hospital No: Address: (affix label) ……………………………………………………….…………………… … Age: …………………………………………………………………………….… Weight: kg Description of seizure(s) requiring emergency medication: If the seizure lasts longer than …… minutes or has a cluster of serial seizures lasting over …… minutes GIVE PRESCRIBED DOSE OF BUCCAL MIDAZOLAM[ EPISTATUS] Prescribed dose mg Amount to be given in mls Route: Buccal This will take approximately 5-10 minutes to have the desired effect A paramedic ambulance should be called for the very first time Buccal Midazolam is given Individualise plan as required OR If no response to first dose call Paramedic after _ minutes > give second dose DOSE mg Thereafter for subsequent seizures you may need to call 999 if: The emergency medication fails to have effect The person experiences breathing difficulties Recovery is slow, an injury is sustained Consultant Name : Print _ Signed. Date: _ REVIEW DATE Consent given for the implementation of the Guideline by Young person/parent/guardian Young person :Print name Signed: Date: Parent/Guardian: Print name Signed: _ Date: Name of Professional giving training: Print name: Signed _ Date _ Copies to: File Parent/s GP School Nurse Health Visitor Other ……………………… … © Worcestershire Acute Hospital NHS Trust Guideline for doctors, nurses and parents/carers on the use of Buccal Midazolam in children Page of 12 WAHT-PAE-067 This guideline has been printed from the Worcestershire Acute Hospitals NHS Trust intranet on 19/10/2022,02:41 It is the responsibility of every individual to check that this is the latest version/copy of this document Appendix 2: See Document Management System for printable version Record of Buccal Midazolam Administration at Home Child’s name: Child’s date of birth: Date and time of fit: Description of fit: Date and time of giving midazolam: Dose (mls) given: Preparation used Epistatus PREPARATION 10MGS /1 ML) Paramedic Ambulance called? Yes No Time: Did the fit stop after the midazolam was administered? Yes/No If yes, how long after the midazolam? Any comments, adverse reactions, hospital admission? (please describe) This form should be returned to: Sharon Dawe Epilepsy Specialist Nurse Children’s Outpatient Clinic Or Dr M Hanlon Consultant Paediatrician, Worcestershire Royal Hospital, Charles Hastings Way WORCESTER WR5 1DD Thank You © Worcestershire Acute Hospital NHS Trust Guideline for doctors, nurses and parents/carers on the use of Buccal Midazolam in children Page of 12 WAHT-PAE-067 This guideline has been printed from the Worcestershire Acute Hospitals NHS Trust intranet on 19/10/2022,02:41 It is the responsibility of every individual to check that this is the latest version/copy of this document Appendix : See Document Management System for printable version Information for parents about Buccal Midazolam (Epistatus) What I if my child has a seizure? • Stay calm • Note the time and keep checking how long the seizure is lasting • Loosen any tight clothing around the neck • Protect your child from injury • Cushion your child’s head if he or she has fallen on to the floor • Once fit has stopped gently place your child in the recovery position • Stay with your child until he or she is fully recovered • DON’T try to restrain your child while having the fit • DON’T force anything between the teeth • DON’T try to move your child unless he or she is in danger • DON’T give any drinks until he or she is fully recovered If a seizure continues for more than five minutes, the buccal midazolam is given to stop the seizure before it leads to status epilepticus When buccal midazolam is being given for the first time ever, the paramedic ambulance should be called by dialling 999 If your child has had buccal midazolam before you not need to call the ambulance However, you will need to call the ambulance if the initial dose of buccal midazolam has not had any effect on stopping the seizure within 10 minutes, or there are difficulties in giving the medication When you dial 999, state that you need an ambulance for a child having a seizure and that you are giving buccal midazolam Give your full address and postcode as the control centre may be in another part of the UK Don’t hang up the phone until ambulance control tells you to Do not leave the child unattended until he/she has fully recovered Ensure the child’s privacy and dignity is maintained as much as possible at all times What is status epilepticus? Status epilepticus is a seizure (convulsion or fit) or a series of seizures lasting for 30 minutes or more without complete recovery of consciousness It is a medical emergency © Worcestershire Acute Hospital NHS Trust Guideline for doctors, nurses and parents/carers on the use of Buccal Midazolam in children Page of 12 WAHT-PAE-067 This guideline has been printed from the Worcestershire Acute Hospitals NHS Trust intranet on 19/10/2022,02:41 It is the responsibility of every individual to check that this is the latest version/copy of this document What is midazolam? Midazolam is a medicine which is similar to diazepam Diazepam is often used for the treatment of epileptic seizures (convulsions or fits), by the rectal route (into the child’s bottom) in emergencies Midazolam is as effective as diazepam and has the advantage of being given by the buccal route (into the side of the child’s gums and cheek) The midazolam is directly absorbed into the blood stream and does not have to be swallowed What are the side effects? • Drowsiness and sedation -recovery is fast • Amnesia-short term memory loss is common Your child may not remember having a seizure • Breathing difficulties-an effect on breathing is very unlikely to occur, if midazolam is used in the dose prescribed This is the reason for calling an ambulance when you give the very first dose What is the usual reaction to midazolam? • With some sedation, ending of the seizure is expected within a few minutes • Flushing of the skin, or a rash of pink spots may appear but these should subside within 15 minutes • How your child will react to the medication is difficult to describe until the first time midazolam is given Measuring and giving midazolam • Give midazolam when the seizure has been going on for … … minutes • Hold the bottle upright and remove the child resistant cap • Push the plunger of the empty one ml oral dispenser completely down towards its tip • Insert the tip of the oral dispenser into the hole of the white plastic bottle adaptor • Hold the bottle and oral dispenser securely and turn the bottle upside down • Pull the plunger down until the oral dispenser contains ……………………….ml • • • • • • • Turn the bottle upright and remove the oral dispenser from the bottle Check that the oral dispenser contains the right amount of medication and that the liquid is clear Explain to the child what is going to happen Open the child’s lips, place the end of the dispenser between the gum and cheek, the cheek nearest to the floor and slowly drip the midazolam solution into the buccal area of the mouth If a small amount of the midazolam is swallowed, this is not a problem Screw the child resistant cap back onto the bottle immediately; this is important as the fluid can evaporate but also crystallise making it cloudy Put the bottle back into the carton, store upright © Worcestershire Acute Hospital NHS Trust Guideline for doctors, nurses and parents/carers on the use of Buccal Midazolam in children Page of 12 WAHT-PAE-067 This guideline has been printed from the Worcestershire Acute Hospitals NHS Trust intranet on 19/10/2022,02:41 It is the responsibility of every individual to check that this is the latest version/copy of this document If buccal midazolam does not control the seizure within five minutes, call an ambulance by dialling 999, if you have not done so already © Worcestershire Acute Hospital NHS Trust Guideline for doctors, nurses and parents/carers on the use of Buccal Midazolam in children Page 10 of 12 WAHT-PAE-067 This guideline has been printed from the Worcestershire Acute Hospitals NHS Trust intranet on 19/10/2022,02:41 It is the responsibility of every individual to check that this is the latest version/copy of this document Recording After administering the midazolam, it is important to record that you have done so The form you use should include: • the medication you gave, • the dose/amount given, • the route of administration • the date and time it was given The incident should also be noted, including a description of the seizure and the length of duration and action taken It should also include information about what happened to the child following the administration of the midazolam The Epilepsy Specialist Nurse will hold the information and it will be used to audit and monitor the use of midazolam The child’s Consultant or ESN must be informed if there is a significant increase in the frequency or severity of the child’s seizures REPORTING • The administration of the medication should be reported to the parents as soon as possible [It may be that friends or relatives have given this medication.] • If an ambulance has been called the paramedics must be informed of the dose of midazolam given and time of administration Important information you should know: STORAGE • Keep medicines in a safe place where children cannot reach them • Keep midazolam at room temperature, away from bright light or direct sunlight and away from heat Do not store in a fridge • If the doctor decides your child should stop taking midazolam, return any remaining medicine and dispensers to your pharmacist • You may not be using midazolam regularly, so please check the expiry date of the product periodically • Your child may also have been prescribed rectal diazepam for epileptic fits lasting longer than five minutes • It is important to remember that either buccal midazolam or rectal diazepam should be given, not both Each person reacts differently to medicines and so your child will not necessarily suffer from any or all of the side effects mentioned If you are concerned about any of the side effects or want more information about how to administer midazolam by the buccal route, or have any questions or concerns, please ask your consultant, nurse or pharmacist © Worcestershire Acute Hospital NHS Trust Guideline for doctors, nurses and parents/carers on the use of Buccal Midazolam in children Page 11 of 12 WAHT-PAE-067 This guideline has been printed from the Worcestershire Acute Hospitals NHS Trust intranet on 19/10/2022,02:41 It is the responsibility of every individual to check that this is the latest version/copy of this document CONTRIBUTION LIST Key individuals involved in developing the document Name Designation Sharon Dawe Epilepsy Specialist Nurse Dr M Hanlon Paediatrician Circulated To The Following Individuals For Comments Name Designation Dr J E Scanlon Consultant Paediatrician Dr Dawson Consultant Paediatrician Dr D Castling Consultant Paediatrician Dr G Frost Consultant Paediatrician Dr A Gallagher Consultant Paediatrician Dr Bindal Consultant Paediatrician Dr K Nathavitharana Consultant Paediatrician Dr Ahmed Consultant Paediatrician Dr A Short Consultant Paediatrician Clinical Director Dr A Mills Community Paediatrician Dr F Childs Community Paediatrician Mrs R Johnson Consultant A&E, WRH Mrs S Crawford Consultant A&E, WRH Mr N Kumar Consultant A&E, WRH Mr R Morrell Consultant A&E, Alex Chris Hetherington Consultant A&E, Alex Mr P Byrne Matron A&E, Alex Mrs S Smith Matron A&E, WRH Matt Kaye Clinical Pharmacist Sarah Scott Clinical Pharmacist Dana Picken Matron Lara Greenway Ward Manager – Ward Alex Nell Pegg Ward Manager - Riverbank Melanie Chippendale Advanced Nurse Practitioner Richard Stock Professional Development Dr T El-Azzabi Consultant Paediatrician Dr David Lewis Community Paediatrician Dr Jo Crane Community Paediatrician Dr V Weckemann Consultant Paediatrician Dr C Onyon Consultant Paediatrician Dr M McCabe Lead paediatric anaesthetist Dr G Sellors Clinical Director critical care Circulated To The Following CD’s/Heads Of Dept For Comments From Their Directorates / Departments Name Directorate / Department Steph Courts Orchard Service Gail Bradford A/E Dept WRH Julie Clissett Children with learning disabilities and complex needs Shap Drive Worcester Jayne Collins Children with learning disabilities and complex needs Wyre Forest Karen Hall Children with learning disabilities and complex needs Alex Bryer Stafford Epilepsy specialist nurse Adult LD Robertson unit KGH Sally Wright Learning Disabilities WRH Circulated To The Chair Of The Following Committees / Groups For Comments Name Committee / group Alison Smith Medicines Safety Committee © Worcestershire Acute Hospital NHS Trust Guideline for doctors, nurses and parents/carers on the use of Buccal Midazolam in children Page 12 of 12 ... documentation for the administration of buccal midazolam [Appendix 2] To provide parents and carers with the information and training in the management of acute seizures and the indication of when and. .. version/copy of this document GUIDELINE FOR DOCTORS, NURSES AND PARENTS/ CARERS ON THE USE OF BUCCAL MIDAZOLAM FOR PROLONGED SEIZURES IN CHILDREN INTRODUCTION WHY DO WE ADMINISTER BUCCAL MIDAZOLAM? ... place the end of the dispenser between the gum and cheek, the cheek nearest to the floor and slowly drip the midazolam solution into the buccal area of the mouth If a small amount of the midazolam