Download - Salford Royal NHS Foundation Trust

Auditory Brainstem Response
Audiometry under Sleep induced by
Melatonin
Classification: Policy
Lead Author: Drs Kumar Sakthivel and Mohammed
Iqbal
Additional author(s): Lesley Stanley and Paul Oddie
Authors Division: Salford Health Care. Children’s
Service.
Unique ID: TWCG13(15)
Issue number: 2
Expiry Date: November 2017
Contents
Intro
Section
Page
Who should read this document
Key practice points
Background/ Scope/ Definitions
What is new in this version
Policy/Procedure/Guideline
Standards
Explanation of terms
References and Supporting Documents
Roles and Responsibilities
2
2
2
4
4
6
7
8
8
Appendix
1 Letter to GP
2 Letter to parents/carer
3 Care plan
9
10
11-14
Document control information(Published as separate document)
Document Control
Policy Implementation Plan
Monitoring and Review
Endorsement
Equality analysis
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Who should read this document?
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Audio-Vestibular Physician
Paediatricians
Audiologists
Nursing staff at Pendleton Gateway
Panda Unit Salford Royal Hospital
Any staff considering use of melatonin for other
investigations/procedure.
Key Practice Points
This policy ensures:
1. Diagnosis of hearing loss in children who are difficult to test by
conventional methods or will not sleep for objective testing by Auditory
Brainstem Response Audiometry (ABR test).
2. Use of the medicine, Melatonin, off-license to induce sleep in selected
group of children to avoid administration of general anaesthetic. Please
note that Circadin product is a licensed product but we are using it in
an off license way (to induce sleep for a test) in this situation
3. Explanation of the test procedure to the family, using interpreter when
required.
4. Providing verbal and written information to the family
5. Clear and accountable roles and responsibilities shared by the multidisciplinary team ensuring smooth testing process and safety of the
child
Background/ Scope/ Definitions
Melatonin
Melatonin is a hormone found naturally in the body.
Melatonin used as medicine is usually made synthetically in a laboratory.
People use melatonin to adjust the body’s internal clock. It is used for jet lag,
for adjusting sleep-wake cycles in people whose daily work schedule changes
(shift-work disorder), and for helping severely vision impaired people establish
a day and night cycle.
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Melatonin is also used for the inability to fall asleep (insomnia); delayed sleep
phase syndrome (DSPS); insomnia associated with attention deficithyperactivity disorder (ADHD); insomnia due to certain high blood pressure
medications called beta-blockers; and sleep problems in children with
developmental disorders including autism, cerebral palsy, and mental
retardation. It is also used as a sleep aid after discontinuing the use of
benzodiazepine drugs and to reduce the side effects of stopping smoking.
Some people use melatonin for Alzheimer’s disease, ringing in the ears,
depression, chronic fatigue syndrome (CFS), fibromyalgia, migraine and other
headaches, irritable bowel syndrome (IBS), bone loss (osteoporosis), a
movement disorder called tardive dyskinesia (TD), epilepsy, as an anti-aging
agent, for menopause, and for birth control.
Other uses include breast cancer, brain cancer, lung cancer, prostate cancer,
head cancer, neck cancer, and gastrointestinal cancer. Melatonin is also used
for some of the side effects of cancer treatment (chemotherapy) including
weight loss, nerve pain, weakness, and a lowered number of clot-forming cells
(thrombocytopenia).
It is also used to calm people before they are given anaesthesia for surgery.
In USA, Melatonin is available without prescription from health shops and is
readily available through internet to anyone.
In UK, Melatonin is not licensed for use in Children but is available on
prescription by a doctor for conditions described above for short or intermittent
use.
Melatonin has been used for MRI scan and EEG in some centres and its use
is gaining strength to induce sleep in children for physiological tests like
Auditory Brainstem Response Audiometry (ABR). Clinician can prescribe
Melatonin if such a use is considered beneficial for the health or investigation
of the child.
There are many children who are difficult to test by conventional hearing tests
and/or will not sleep naturally for ABR.
ABR
ABR test involves attaching three electrodes, one to the forehead and one
behind each ear. The sound is presented via air conduction through
headphones or ear inserts. It will also be presented through a bone
conduction transducer placed behind the ear. When sound passes through
the nerve, electrical potentials are detected on the scalp and recorded on a
computerised system, and thresholds of hearing can be determined for air
conduction and bone conduction across the frequency range.
Any movements by the patient create myogenic potentials that interfere with
the recording preventing an accurate result. Also sounds produced by the
patient i.e. crying will also affect the recording. It is therefore essential for
children who will not fall asleep naturally in the clinical setting, that sleep can
be induced by Melatonin avoiding the need for general anaesthetic.
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The Consultant Audio-Vestibular Physician will be responsible for the overall
care of the child.
The policy also provides a clear process map for roles and responsibilities of
the multi-disciplinary team and safe practice including safety of child.
This policy document will allow clinicians to prescribe Melatonin safely for
children where contraindication does not exist.
What is new in this version?
Appendix 3. Care plan for procedure
Policy/ Guideline/ Protocol
Rationale:
This policy aims to ensure that there is complete understanding by the family
regarding the need of the Melatonin administration for ABR.
Written information about Melatonin including what to expect on the day and
thereafter is provided to the family/guardian
Written information also informs the family/guardians of the side effects in a
format that can be fully understood in order to reduce any concerns
The policy ensures that there is no medical contraindication in the selected
group
The policy ensures that there is good liaison between the different teams
The policy ensures the safety of the child
Protocol:
1. The child will be identified by the Audiology Team who requires further
audiological investigation and will consist of those who were found
difficult to test under natural sleep previously or when there is strong
suspicion by the Audiologist as a result of previous clinical consultation
that they are unlikely to sleep naturally for ABR and cannot be tested
by conventional audiological methods.
2. Consultant Audio-Vestibular Physician has the overall responsibility for
the care of the child will discuss the need for the prescription of
Melatonin to induce sleep for ABR with the family and will provide a
written leaflet for use of Melatonin for ABR test.
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3. The Consultant Audio-Vestibular Physician will complete care plan and
obtain consent from parent (Appendix 1)
4. The Consultant Audio-Vestibular Physician will write to the patients G.P
to ask if any contra indications for proposed test (Appendix 2)
5. The Consultant Audio-Vestibular Physician will write the prescription for
Melatonin.
6. Nursing In charge at Pendleton Gateway will ensure that the
medication is available on the day of testing.
7. If the ABR is required whilst the Consultant Audio-Vestibular Physician
is on leave the responsibility will be taken over by nominated
Paediatrician who will be informed prior to consultant leave. This
should only be undertaken if the test is required on an urgent basis.
In special circumstances where the child may have complex health
needs it may be necessary for a paediatrician to be present throughout
the session. This will be arranged by Consultant Audio-Vestibular
Physician.
8. Testing will be done in the morning date and time to be agreed with
children’s outpatients
9. Administration of Melatonin will be for the children under the age of 16
attending for ABR.
10. Patient Exclusion: Children with the following conditions will be
excluded from administration of Melatonin as Melatonin contains 80mg
Lactose monohydrate:
7.1 Galactose Intolerance
7.2 LAAP Lactase Deficiency
7.3 Glucose-Galactose malabsorption
7.4 Hypersensitive to Melatonin or above excipients
11. The date and time will be arranged by audiology administration staff
with children’s outpatients and the audiologist . If an interpreter is
required this will be arranged by audiology administration staff.
12. A letter will be sent to the child’s parents with date and time of
proposed test and advice regarding preparation of their child (Appendix
3)
13. Children’s outpatient nursing staff will administer the melatonin as
prescribed approximately 45 minutes before the test. This can be
repeated if the child vomits within 30 minutes of giving the first dose.
14. Melatonin is available as a dose of 2 mg (1 tablet of 2 mg strength).
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2 mg dose will be administered to children under the age of 5
years
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5 mg dose (two and half tablets of 2mg strength tablet) will be
administered to children over the age of 5 years.
15. The ABR test takes between 60 minutes to 90 minutes depending on
how deeply the child is asleep and the ease of getting the response.
Rarely it can take up to 2 ½ hours.
16. Nursing staff will check the child before considering discharge. The
child will be discharged when they are awake and not showing any side
effects.
17. The Nursing team will consult the doctor if any concerns or if the
parents express concerns.
18. If there is any concern about the child’s health, the child will be
transferred to the Panda Unit at Salford Royal Hospital by an
ambulance via 999 calls.
Standards
1. There are no standards available for the use of Melatonin for tests like
ABR.
2. There is no guideline by DoH, GMC and NICE
3. However, Schmidt et all (please see Reference section) found that the
Click tests were successfully performed in 216 of 249 children or 86.7%
(123 male, 93 female), notched-noise tests in 115 of 155 children or
74.2%. Failure rates showed an age dependence increasing from 4%
in children <1 year to 25%>3 years, but no gender difference.
4. This suggest that Melatonin will be successful in 70% of children tested
for ABR
5. Melatonin is gaining its use to avoid general anaesthetic for ABR
testing and is being used in few hospitals in UK.
Explanation of terms
1. ABR means Auditory Brainstem Response Audiometry and this is an
objective test performed in babies under the age of 6 months when
they show no clear response to new-born hearing screening or in
children over the 6 months when they are difficult to test by
conventional methods.
2. Air conduction means sound is presented to outer ear and it travels
through the outer ear and middle ear to the inner ear and nerve of
hearing. This is called air conduction.
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3. Bone conduction means sound is presented through a bone conducting
transducer to the mastoid bone and it bypasses the outer and middle
ear to reach the inner ear directly.
4. Audit means an official examination and verification of accounts and
records, and comparing them with the like for like standard in that
industry.
5. Frequency is defined as a number of cycles per second and it’s unit is
called Hertz, usually written as Hz. in an abbreviated form. Frequency
is a measure of the pitch of the sound. Low frequency (low pitched)
sounds will have fewer cycles per second (e.g. 250-1000 Hz) and high
frequency (high pitched) sounds will have a higher number of cycles
per second (e.g. 3000-8000 Hz).
6. Melatonin is a hormone found naturally in the body and is also used as
medicine made synthetically in a laboratory.
7. Lactase Deficiency: Lactose intolerance is the inability to digest and
absorb lactose (the sugar in milk) that results in gastrointestinal
symptoms when milk or food products containing milk are consumed.
8. Glucose-Galactose malabsorption: Glucose-galactose malabsorption is
a condition in which the cells lining the intestine cannot take in the
sugars glucose and galactose, which prevents proper digestion of
these molecules and larger molecules made from them.
References and Supporting Documents
1.Schmidt CM, Knief A, Deuster, Matulat P, Zehnoff-Dinnesen AG Melatonin
is a useful alternative to sedation in children undergoing brainstem audiometry
with an age dependent success – a field report of 250 investigations
Neuropaediatrics 2007; 38(1): 2-4
http://www.ncbi.nlm.nih.gov/pubmed/17607596
“Conclusion: Melatonin-induced sleep is a good alternative to sedation,
especially in children younger than 3 years. This method is widely accepted
by parents and permits earlier diagnosis of hearing impairment in a routine
clinical setting. The number of children undergoing general anaesthesia for
ABR investigation was reduced from over 60 per year in 2000-2002 to 12 in
2005, which means >80% less general anaesthesia”.
2. Medlineplus-Information about Melatonin
http://www.nlm.nih.gov/medlineplus/druginfo/natural/940.html
3. Sleep EEG guidelines Royal Manchester Children’s Hospital.
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Roles and responsibilities
Roles and responsibilities have been clearly explained in section Policy/
Guideline/ Protocol
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Appendices
Appendix 1
Letter to GP:
Dear Dr………………….
Reference: (Details of the child)
We are planning to use Melatonin for ABR testing on ………………..
I would be most grateful if you would kindly confirm if you have any information
to suggest that the child is suffering from any of the following conditions:
Galactose intolerance
Lactase Deficiency
Glucose-Galactose malabsorption
Any other significant condition
Kind regards
Signature
Consultant Audio-Vestibular Physician
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Appendix 2
Letter to Parents/Guardian
Dear Parents/Guardian
Reference:
In order for the Melatonin to be effective to induce sleep for the test, it is very
important that your child is not allowed to have a full night’s sleep the night
before the testing.
Older babies and toddlers
We would like you to keep your child awake for several hours before the ABR
testing, so that they will take a nap in the department after we have fitted the
sensors. Please ensure that you have available anything that would normally
help your child to settle, such as their bedtime toys or blanket, a dummy or
drink.
Three years plus and school age children
To help us get a successful ABR test in all older children, please deprive them
of adequate sleep the night before the testing. This means keeping them up
later, usually by 2-3 hours, and getting them up early on the morning of the
testing. You then need to make sure they are kept active until the appointment
and are not allowed to doze off in a pushchair or car.
Adolescents
Please follow the instructions for school age children, but with extra sleep
deprivation. With some older teenagers we may give an appointment early in
the day; in this case more sleep deprivation is needed, particularly waking your
child up earlier than normal. You might want to let your child stay up all night
(watching DVDs etc) so they are much more likely to fall asleep in the morning.
Please see the enclosed leaflet and do not hesitate to contact me through my
secretary if you have any questions, please contact:
Lesley Cass, Secretary to Dr Iqbal Telephone: 0161 2125599
Kind regards
Mohammed Iqbal
Consultant Audio-Vestibular Physician
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Appendix 2
Care plan
First Name:
Surname:
Date of Birth:
NHS Number:
Address:
Tel:
GP:
Allergies/Intolerances:
Relevant medical History
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Consent
Name……………………………………………… NHS No.
………………………….
DOB …………………………………………………………
I …………………………………………………………….. have consented for
……………………………………………………. to have a sensitive hearing test.
The procedure has been explained to me and I understand that Melatonin
medication will be given to help my child sleep for the required hearing test.
Signature Parent/carer ……………………………………………………….
Date ………………………….
If interpreter used they should also sign
………………………………………………..
Leaflet
procedure
Signature …………………………………….
complications
Date ………………………..
Mohammed Iqbal
Consultant Audio-Vestibular Physician
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Medication Prescription
Name………………………………………………………… NHS No …………………………………….
DOB
……………………………………………………..
Dose: Circadin®MR tablet 2mg for children equal or less than the age of
5
Dose: Circadin®MR tablet 5 mg for children above the age of 5 (2 ½
tablets)
Timing: 45 minutes before performing the ABR
Date
Drug
Circadin
Dose
Print
Signature
Mohammed
Iqbal
To be
repeated if
child
vomits
Mohammed
Iqbal
Circadin
Record of medication adminstered by nursing staff
Date
Time
Dose
Signatures
Please sign again if the second
dose is required
Name………………………………Nhs No ……………………………………….
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DOB …………………………………………………………
Date……………………………………………
……………………………………………………………….. Is fully awake
following the ABR and is safe to return home under
the care of ……………………………………………………………….
Written and verbal instructions given
Signatures
Nurse ………………………………… Parent/guardian
……………………………………..
……………………………………Needs further observation following their ABR
Doctor signature ………………………………
For transfer to PANDA
Paediatrician on-call informed
Observations
Sa0²
Respiratory rate
Pulse
GCS
Child safely transferred to PANDA
Signature ……………………………………………………
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