Epilepsy

One of the most common serious neurological conditions in the world. In Scotland there are approximately 54, 000 people with active epilepsy affecting all ages.

Status epilepticus

A life-threatening neurological condition defined as five or more minutes of continuous seizure activity or repetitive seizures without regaining consciousness between episodes. On average, 20% of cases are fatal, although studies have reported mortality rates as high as 57% in adults. Most patients have a background of epilepsy; however a number of secondary causes should be considered, including stroke, infections, trauma, metabolic disorders, inflammatory conditions, CNS tumours and drug overdose.

Status epilepticus can be classified based on a number of clinical features:

• Tonic-clonic status epilepticus (generalised or focal evolving). Paroxysmal or continuous tonic-clonic motor activity that may be symmetrical or asymmetrical with impaired awareness. This variant of status epilepticus is the most common and has the highest associated morbidity and mortality. As a result most of the evidence for treatment interventions has focused on this patient group. 
• Focal aware motor status epilepticus
• Motor seizures localised to one side of the body with retained consciousness.
• Status epilepticus without prominent motor symptoms

These include a number of variants: impaired awareness cognitive status epilepticus (coma, obtundation, confusion, disorientation, confusion, disorientation, behavioural disturbance etc.), absence status epilepticus and focal impaired awareness status epilepticus.

Most convulsive seizures terminate spontaneously within three minutes and do not need emergency treatment.

After five minutes of continuous seizure activity, the sooner treatment is initiated, the better the chances of seizure termination, and the lower the risk for adverse consequences.

Emergency treatment should be sought or given once a seizure has persisted, or there is a series of seizures, for five minutes or more.

Administration of buccal midazolam is an emergency procedure, but it does not require a nursing or medical qualification. It can be administered at home, in social care and other non-health settings and is a procedure that may safely be undertaken by any worker or carer who has received up to date training in epilepsy and the administration of oromucosal midazolam. It is expected that all staff who undertake training will carry out the procedure safely and appropriately.

Prior agreement to training and implementation of the policy will have been agreed with the employing agency. For employed staff it is the employers’ responsibility to ensure that named individuals are taught to administer buccal midazolam in conjunction with training about epilepsy and that the training is adequate and up to date.

Health professionals will lead on this training. All training provided should be in line with the Best practice guidelines for training professional carers in the administration of Buccal (Oromucosal) Midazolam, by ESNA, ILAE + RCPsych. 

This applies to:

• Social services staff within day and residential services
• Health services staff within residential and support services
• Parents and carers, where in agreement
• Private and voluntary sector service providers, where in agreement
• Staff within further or continuing education establishments

According to the job description and supervision of the employing agency all non-health persons administering buccal midazolam do so as a caring person and not as a medically trained practitioner.

It is recommended that 3rd sector care providers have an inhouse trainer who has attended the Quarriers Epilepsy Centre for train the trainer course. There is also training available from Epilepsy Scotland

It remains the responsibility of the participant’s employer to monitor and assess workplace competence, as the trainer will be unable to assess individuals in the course of their work.

Training updates should be given every two years. If the participant has not used the procedure in a work situation in one year, an interim refresher course is recommended. It is the responsibility of the employing agency to organise training updates.

Treatment protocol (NHS Highland intranet access required).

The healthcare professional who initiates the prescription for midazolam is responsible for completing the treatment protocol in conjunction with others involved in the care of the individual. It includes:

• A brief description of the individual’s expected seizure patterns including nature of seizures, frequency, duration, pre-disposing factors, recovery and specific first aid instructions
• Precise instructions for administration
• When and if a second dose may be given
• When emergency assistance should be sought
• Who should be informed and when
• Awareness of supporting documentation

NB: there is often an important exception to the 5 minute delay and carers may be advised to administer midazolam immediately to patients who are known to suffer prolonged seizures.  It should be documented on the patients’ individual treatment protocol when to administer midazolam.

Shared care

Oromucosal  midazolam should be prescribed when the risk of status epilepticus is considered to be greater than the risk of administering oromucosal midazolam. This risk can be determined in terms of the frequency of epileptic seizures, their type and severity, including duration.

Initial recommendation for its use will be made by a consultant neurologist, consultant learning disability psychiatrist, specialist epilepsy nurse or a general practitioner with a special interest in epilepsy.

If in agreement with the treatment protocol, subsequent prescribing will be undertaken by the primary care prescriber.

Indication

• Status epilepticus as per patient's treatment protocol.
  • For seizures longer than 5 minutes of continuous seizure activity.
  • In some patients initial administration may be sooner than 5 minutes, eg, if the patient is known to have prolonged seizures.

Dose (as per BNF and BNFC)

• Adult: 10mg, then 10mg after a further 10 minutes, if required

Prescription

• Midazolam is a Schedule 3 controlled drug; therefore the prescription is to be written in accordance with the prescription requirements for Schedule 3 controlled drugs.
• Oromucosal midazolam is to be prescribed as the brand 'Epistatus'.
  This is the product of choice in NHS Highland for clinical and safety reasons and to ensure patients and their carers receive the product they have been trained to administer and are familiar with.
• Epistatus comes as a range of preparations with different licenced indications.
• The choice of preparation is chosen by the Adult or Paediatric Specialist Epilepsy teams and will be stated on the patient’s treatment protocol.

Adverse effects (See BNF and BNFC for full details)

• Confusion, drowsiness and appear tired.
• Agitated, restless and excitement, they may appear more alert and want to move around.
• Unsteady on their feet

Interactions (See BNF and BNFC for full details)

• Plasma midazolam concentrations are markedly increased by co-administration of antibacterials (erythromycin, clarithromycin) and antifungals (ketoconazole, itraconazole, and fluconazole). Reduce the midazolam dose by 50 to 75% when these drugs are co-administered.
• Avoid concomitant use of midazolam with HIV-protease inhibitors, eg, ritonavir due to the risk of extreme sedation and respiratory depression.

First-line

• Midazolam (Epistatus) oromucosal (buccal) solution 10mg/mL
• Dose based on age or weight as per patient’s treatment protocol

Ideally the person administering the medication should know the individual.

If possible two people should be present, both for individual support and to facilitate the continued monitoring of the patient while summoning emergency assistance.

If the person administering the medication feels unsure, is concerned in any way regarding the person’s seizure(s) or feels the use of medication is inappropriate, they should contact the relevant emergency medical services (999, NHS24, GP or ambulance service).

Administration

• The normal route of administration is the buccal route.
• Using the oral syringe provided, administer about half of the prescribed dose to each buccal cavity (cavity between the gums of the lower jaw and the cheek) over 2 to 3 seconds.
• If the patient is very difficult to control, then administer the whole dose to one buccal cavity over 4 to 5 seconds.
• The intranasal route can be used in exceptional circumstances, eg, excessive salivation. Midazolam should be dripped into each nostril.

Time of onset and duration of action

• Initial effects become apparent after approximately 5 minutes.
• About 80% of seizures are terminated by oromucosal midazolam within 10 minutes.
• A second dose should only be given 10 minutes after the first dose if the patient is still experiencing seizures. This must have been previously agreed and documented in the treatment protocol.
• A person may remain drowsy or significantly sedated for several hours after administration of midazolam.
• A second course of treatment must not be administered sooner than 12 hours after the first course. If a second course of treatment is required within a 24-hour period, midazolam should be administered as per the treatment protocol and an ambulance phoned.

Adverse effects (See BNF and BNFC for full details)

• Confusion, drowsiness and appear tired.
• Agitated, restless and excitement, they may appear more alert and want to move around.
• Unsteady on their feet

Monitoring

• Observe colour and check that the chest and abdomen are moving appropriately with breathing.
• If there is concern about these, or there is a delay in regaining consciousness, seek emergency medical assistance as detailed in patient’s treatment protocol.
• If attended by a nurse/doctor the patient’s vital signs should be monitored every 15 minutes for the first hour, then every 30 minutes for the next three hours.
  • respiratory rate
  • pulse
  • blood pressure
  • temperature
  • skin colour

Treatment of overdose

Overdose can be treated with the benzodiazepine antagonist flumazenil.

This can ONLY be administered intravenously by a doctor. See BNF for dose.

• Reversal of sedative effects of benzodiazepines in anaesthesia and clinical procedures.
  Adult: BY INTRAVENOUS INFUSION
  
  • 200 micrograms over 15 seconds,
  • then 100 micrograms every 1 minute if required;
  • maximum 1mg per course

Record of administration

• Record the administration of midazolam on the appropriate documentation for your organisation.
• If there is a seizure chart in use, record the seizure on the chart.

Storage

• Epistatus (midazolam 10mg/mL oromucosal solution) both the pre-filled syringes and 5mL bottle of solution should be stored below 25°C
• Epistatus 5mL bottle of solution - the cap on the bottle should be replaced as soon as possible after use. This is because the liquid will evaporate and some of the active ingredient will precipitate, this will appear as white particles in the liquid. The pack must be discarded if the solution is not clear.
• It is not a legal requirement under the controlled drugs regulations to store midazolam in a locked cupboard. However, midazolam (a benzodiazepine) has significant potential for misuse or abuse therefore; it is recommended that midazolam is stored in a secure location, ideally in a locked cupboard.

Wherever possible, consent for administration should be gained in advance from the person receiving the medication.

Where the person does not have capacity to consent (itself subject to formal assessment) a Certificate of Incapacity under Section 47 of the Adults with Incapacity (Scotland) Act 2000 should be completed. A Certificate of Incapacity is required even if the individual has a welfare guardian who can consent to medical treatment on their behalf.