1. Buccal/ Nasal Midazolam
Seizure Rescue Medication
Training
Learning Disability Nursing
Epilepsy/ Midazolam Training Pack
Trainers Notes
LD ESN June 2009

2. Learning Outcomes You will
Be able to recognise prolonged and serial seizures and respond appropriately
Be able to describe the appropriate conditions required to participate in the administration
Be able to demonstrate through simulation the procedure for administering midazolam
LD ESN June 2009

3. What is Midazolam?
Is the pharmaceutical name for this drug, from a family of similar drugs called Benzodiazepines
Other names and formulations for Midazolam include Hypnoval and most commonly Epistatus
Midazolam is licensed as a sedative it is used in hospitals and clinics before clinical procedures.
In the brain it acts as an effective anti epileptic
Midazolam: What is it?
From the same family/ group of drugs ‘Benzodiazepines’ includes drugs Diazepam, Clobazam, Clonazepam used widely in epilepsy.
Used commonly in Hospitals and clinics as mild sedative to reduce anxiety, used as pre -anaesthesia.
In the brain acts like GABA switches off neurone firing
Tolerance can develop if used frequently, and it has the potential to be addictive also if used frequently. Withdrawal from regular use needs to be done slowly.
Other preparations of midazolam may become more readily available through time – Epistatus has good distribution and currently is the most accessible and cost effective. Other formats include Midazolam injection format in glass ampoules and UL Medicines buccal liquid 10mg/1ml.
LD ESN June 2009

4. How was Midazolam developed for community use?
Used as a sedative since 1988?
Used in epilepsy since 1997
Community use developed in paediatric services/ school age children
Gradual introduction in to adult learning disability
Now the most common form of rescue medication
Recommendations for use in NICE and Paed SIGN, included in most formularies
How was Midazolam developed?
Medicines which are licensed and used for one thing are often found to be useful for other conditions.
Example: AED are often used as mood stabilisers or pain/ headache. A more widely used example could be aspirin as anti coagulant.
Development in children’s medicine was easier because drugs are often unlicensed for use in this population
Rectal Diazepam is rarely prescribed now for children over the age of 5 years.
Buccal nasal Midazolam can be easier to administer offering a choice of sites, particularly the case for wheelchair users, viewed as less stigmatising. Where children and parents are given the choice, Midazolam is much preferred.
NICE – National Institute for standards in Clinical Excellence - Best practice governing body
SIGN – Scottish Intercollegiate Guidelines Network – Independent clinical guide to best practice
Prescribing formularies are local e.g. the Glasgow Formulary – GPs can more confidently prescribe when a drug has been scrutinised for inclusion in the formulary.
LD ESN June 2009

5. How Does Midazolam Work?
Slowly dripped into nasal/buccal cavity
Absorbed through mucosal skin surfaces
Good blood supply to these areas
Travels via the heart and lungs to the brain
Boosts GABA and dampens down seizure activity
How does it work?
Mucosal skin surface in rectum, nose, buccal cavity – porous and good capillary blood supply. Midazolam is absorbed into blood stream, venous blood returns to heart and lungs and gets quickly to the brain
In the brain ( neuron synapses) it boosts GABA (Gamma Amino Butyric Acid) to switch off excessive firing of neurons.
LD ESN June 2009

6. Effects of Midazolam Effective anti epileptic within 10 minutes
Can cause sedation/ severe drowsiness
Recovery rates vary
May irritate nasal passages or cause discomfort to gums
Can (rarely) depress breathing
Can (rarely) cause restlessness/ hyper activity
Over use can cause dependence and be ineffective
Effect of Midazolam
Seizures usually stop seizures within a few mins.
Median time to stop seizures 8mins.
Tmax 30mins
½ life of 143mins (This can occasionally be a disadvantage for particularly long seizure runs)
Irritation often local and transient.
Paradoxical effect i.e. restlessness/ hyperactivity rare. May cause some sleep disturbance. Confusion and amnesia
Respiratory depression (5.5% pts) more likely where breathing already impaired e.g. chest infection/ chest deformity or where larger doses are administered e.g. 20mg +
Signs of respiratory depression include slow / shallow breathing, pallor sometimes cyanosis. If this occurs medical advice/ ambulance should be sought
Some concern that repeated use over short time period may cause damage to the enamel on teeth (no evidence as yet).
Over use can cause addiction, and can stop working as benzodiazepine receptors ignore it.
Overdose antidote is Flumazenil.
LD ESN June 2009

7. Indications for use
Midazolam is prescribed where the individual has a history of seizures which are prolonged/ serial , most commonly with people who also have LD
Prolonged seizures are around 5 minutes for tonic clonic seizures. Serial seizures occur one after the other with no recovery between
Indications for using Midazolam
Midazolam is usually prescribed where there is some history of prolonged/ serial seizures.
Prolonged/ serial seizures are most common in people with Learning Disability.
Prolonged seizure lasting 5 mins for generalised Tonic Clonic. Serial seizures are repeated seizures without recovery.
Seizure build up is a recognised warning indicator of status epilepticus (seizures lasting for 30 mins).
Midazolam is used early on in the seizure development to try to prevent status epilepticus therefore has to be accessible at home/ work.
An added reason /indication for prescribing/switching from R.diazepam if the individual uses a wheel chair
LD ESN June 2009

8. Indications for Use 2.
Midazolam is used as a rescue medication early on in the development of the seizure/s to try to prevent status epilepticus, improve outcome from seizure/s and quality of life
Status Epilepticus is a continued state of seizure lasting for 30 minutes.
The longer a seizure continues the more intractable it becomes, and increasingly more difficult to stop by any means.
Giving midazolam early on in the development of seizure, can prevent the need for very invasive forms of treatment.
LD ESN June 2009

9. Convulsive Status Epilepticus
A continuous Tonic Clonic seizure or repeated Tonic Clonic seizures lasting 30 minutes
This can be life threatening and requires medical attention
Convulsive Status
Tonic Clonic – Stops normal breathing, blood supply de-oxygenates, neurons become damaged and progressively more dangerous as brain function diminishes.
Neuron damage and death can occur.
LD ESN June 2009

10. Non Convulsive Status Epilepticus
Any seizure can develop into status
Complex partial status relatively common in Learning disability.
This condition can be difficult to diagnose, consciousness is often impaired but not lost completely.
Can continue for long periods.
Can adversely affect health in vulnerable people
Non Convulsive Status
Complex partial/ absence status may make people appear confused/ slow/ disengaged. Physical signs may include minor twitching/ jerking/ of small muscle groups, lowered awareness, postural change, hyper salivation, eye deviation/ closure. Signs can be very subtle. An EEG is often needed to diagnose.
There is a link between health and seizures. More seizure activity adversely and significantly affects swallowing – aspiration risk is therefore much higher. Common in people with multiple disabilities
LD ESN June 2009

11. GP’s and specialists are willing to prescribe
General Information
Most people with LD requiring rescue med are prescribed midazolam (Epistatus)
GP’s and specialists are willing to prescribe
Carers and relatives need instruction in it’s use
For paid care staff recognised training and a signed protocol are essential
General Info
Around 90+ %
In the past, difficulty because of licence – increasingly less of a problem. Although Midazolam remains unlicensed for the treatment of epileptic seizures.
For paid care, the protocol signed by prescriber (usually GP) and good quality training for individuals are pre requisite to Employee Liability Insurance.
As long as employee acts within the protocol guideline and can demonstrate an understanding of the procedure through training they will not be individually liable, but if they do not follow protocol or act outside instruction then will then have individual accountability for those actions.
LD ESN June 2009

12. Midazolam Liquid Sugar free Child proof bottle 4x1ml oral syringes
10mg in 1ml of liquid
Adult dose usually 10mg
Can be given while sitting upright
Epistatus not Licensed at all
Midazolam buccal liquid
Midazolam liquid is far easier and convenient to use that Midazolam Ampoules, which was a fiddly procedure involving glass ampoule, filter straws and syringes. Initially, however this was the only way that people could have Midazolam administered. There are a few individuals who continue to use Midazolam Ampoules.
Great advantage for wheelchair users midazolam should be able to be administered without getting out of chair
10mgs average adult dose, does is weight dependant and small adults may require smaller does.
2 manufacturers now
Special Products – Epistatus
UL Medicines
Special products planning new preparation and delivery method
Special products applying for a license for conscious sedation, this may pave the way to license for epilepsy
LD ESN June 2009

13. Considerations about method of administration
Buccal versus Nasal Route
Type of Seizure
Level of consciousness
Positioning of the individual
How much saliva is produced
Preparation for giving
Things to consider in the administration of Midazolam
If sitting upright in wheelchair, use both sides of mouth.
If lying on the floor/ bed, place pillow/ jacket under shoulders to allow for head to drop back slightly for nasal administration, and use ½ liquid in both nostrils.
If on side, use side of mouth nearest the floor.
If excess saliva, use nose. If small amount, wipe away.
Consider if awareness altered but not lost, Midazolam tastes bitter, person may attempt to spit it out.
Preparation should be as simple as putting on gloves, reading protocol, unscrewing childproof lid and drawing up required amount ready to administer
LD ESN June 2009

14. Buccal Route (side of mouth)
Insert syringe into the mouth, between the lower gum and cheek
Point syringe to back of mouth on insertion then angle downwards into the buccal cavity
Slowly push syringe down until empty
Replace cap on bottle
How to prepare Midazolam
Because of the possibility of an air bubble after, drawing the required amount of midazolam liquid into the syringe you may have to squirt it back into the bottle and re-draw the plunger to the required amount.
LD ESN June 2009

15. Place syringe at the entrance to one nostril
Nasal Route
Place syringe at the entrance to one nostril
Slowly push plunger, dripping midazolam
Alternate between both nostrils
Replace cap on bottle
Buccal or nasal route
Remember slowly will be more effective.
If solution squirted in too quickly, it will go down the back of throat/ nose and take longer to work.
If possible use both sides of mouth, easier with children. In adults depending on position you may need to use just one side.
If during the seizure an injury occurs to either nose or mouth, use uninjured area for administration. If excess saliva is produced from the mouth then use nasal route.
Emphasise administration between lower gums and cheeks, not into oral cavity.
LD ESN June 2009

16. Management of Midazolam
Storage
Shelf life
Recording amount
Recording use
Recording outcome in the epilepsy care plan
Management of Midazolam
Store at room temperature 15-12°C
Immediately replace lid – evaporation causes cloudiness in liquid if this happens, pack must be discarded.
Shelf life is 2 years.
Recording amount is tricky because bottle is not calibrated but should be logged on receipt and each use subtracted from total. Counting syringes is the obvious visible sign of use syringes must be disposed of after one use.
Use of midazolam and the effects/ outcome always recorded in the care plan.
LD ESN June 2009

17. Ethical Issues Duty Of Care Consent Invasive Fear of Legal Action
Duty of care once trained will be to follow protocol and give midazolam when needed as a priority over other considerations (e.g. public place) unless it is unsafe to do so
Eve pre arranged consent is difficult because unconscious at the time of administration. Duty of care overcomes directly obtained consent at the time of need.
AWI section 47 might be helpful
Although invasive, giving medicine into unconscious person, this is a less invasive outcome than status epilepticus treatment in hospital
Rectal Diaz which has same ethical and legal considerations has been in wide use in UK since 1970’s at height 80,000 tubes per annum, no legal action has ever been taken against someone administering this medication for seizures.
LD ESN June 2009

18. Why do we use midazolam in the community? summary
We know that early treatment for seizures is more effective preventing SE
We may be preventing brain damage even death
We may be preventing other poor health (e.g aspiration infection)
Prevents disruption, decreasing hospitalisation
Best outcomes,individual, family and carer
This page offers summary of positive effects of using midazolam in community settings
LD ESN June 2009

19. Joint Epilepsy Council for the UK and Ireland
“When Midazolam is prescribed there should be no unreasonable barriers to its use”
Final statement
Any questions/Discussion
Post training test after a short break
LD ESN June 2009