Patient Support Information

Treating small infantile haemangiomas with topical timolol
What is a haemangioma?
How are haemangiomas usually treated?
What is timolol maleate and how does it help with haemangiomas?
Are there any side effects with topical timolol treatment?
Are there any tests needed before starting timolol treatment?
What dose should my child have and how do I administer it?
Queries/concerns?
Further information

Treating small infantile haemangiomas with topical timolol

This information leaflet explains how small infantile haemangiomas are treated with topical timolol, a medicine historically used to treat high eye pressure (glaucoma). Not all haemangiomas are suitable for this treatment.

There are no topical timolol preparations licensed for treating infantile haemangiomas, so the use of any topical timolol preparation for this condition is “off label”.

What is a haemangioma?

A haemangioma, sometimes referred to as a ‘strawberry birthmark’, is a collection of small blood vessels, which appears red if it’s on the surface of the skin or bluish if deeper. Usually haemangiomas are not present at birth and become apparent within the first few days to weeks. They typically grow rapidly for several months and then shrink slowly over subsequent years.

How are haemangiomas usually treated?

The vast majority of haemangiomas resolve on their own and do not require any active treatment. However, for those that interfere with function (around the eyes, lips, nose or nappy region) beta-blocker medications are the first choice of treatment. They can be given orally (by mouth) or applied topically (as a gel to the surface of the haemangioma). Topical application is generally only used for small haemangiomas.

What is timolol maleate and how does it help with haemangiomas?

Timolol works by making blood vessels narrower, reducing the amount of blood flowing through them. This is useful when treating haemangiomas, as restricting the blood flow helps to reduce the growth, size and redness of the haemangioma faster than would occur without treatment.

Timolol is typically continued until your child is around 12 months old. After stopping treatment, the haemangioma will continue to shrink over the following years. By early school years, depending on the site of the haemangioma there may be little sign it ever existed.

In the minority of cases where topical treatment fails to stop the haemangioma from growing, then an oral beta-blocker medication (called propranolol) may be prescribed in selected cases. Unlike propranolol, timolol doesn’t usually require special monitoring.

Are there any side effects with topical timolol treatment?

Timolol comes in a variety of forms, but the one used at the Royal Belfast Hospital for Sick Children is a gel-forming solution called Timoptol®-LA 0.5%. Topical administration of timolol is safe and side effects are extremely rare, apart from occasional numbness or tingling of the skin at the time of application.

However, you should report any of the following to your doctor as the dose of timolol may need to be altered or stopped. Potential side effects will be explained to you at the first consultation:

• Slow heart rate (bradycardia)
• Low blood pressure (hypotension)
• Low blood sugar (hypoglycaemia)
• Wheeze (bronchospasm)
• Cold hands and feet (peripheral vasoconstriction)
• Low body temperature (hypothermia)
• Sleep disturbance/nightmares.

Are there any tests needed before starting timolol treatment?

If your child has several haemangiomas on the skin, we may carry out an abdominal ultrasound scan to look for haemangiomas deeper in the body. Also, before starting treatment and at several points during treatment your child will have clinical photographs taken to monitor progress.

Please let us know if your child was born prematurely or had a low-birthweight (less than 2.5kg) as this may affect the dose of timolol prescribed.

What dose should my child have and how do I administer it?

The average dose is 1-3 drops twice a day as directed. Apply the drop directly to the haemangioma and carefully spread it with your finger to cover the surface of the haemangioma. Wash your hands before and after putting timolol on your child’s skin.

Queries/concerns?

If you have any queries or concerns please contact our department using the details below, or alternatively discuss with your GP:

Paediatric dermatology secretary
Secretarial office
Basement
Royal Belfast Hospital for Sick Children
Grosvenor Road
Belfast, BT12 6BA
Tel: 028 9063 4482

Further information

British Association of Dermatologists (bad.org.uk)

Birthmark Support Group Tel: 0845 045 4700

Changing Faces | Visible Difference & Disfigurement Charity Tel: 0845 450 0275

What is sclerotherapy?
Why do you need sclerotherapy?
What are the possible risks of having sclerotherapy?
Contrast
Radiation
Pregnancy
Are there any alternatives?
Consent
Pre-assessment
What happens during the procedure?
What happens after the procedure?
What to do when you get home?
Results
Image sharing
Contact us

What is sclerotherapy?

Sclerotherapy is a procedure used to treat rare, non-cancerous growths of vessels called vascular malformations. They are present at birth and tend to grow very slowly but can grow more quickly during puberty and pregnancy.

Sclerotherapy is done using image guidance by an interventional radiologist. It involves injecting a liquid or foam, known as a sclerosant into the vascular malformation to cause it to shrink.

This is typically conducted under local anaesthetic or mild sedation for adults or under general anaesthetic for children. Each treatment lasts around 1-2 hours or may be done repeatedly in smaller stages.

Figure 1:
(A) Vascular malformation before intervention. (B) Shrunken vessels after intervention.

Why do you need sclerotherapy?

Some vascular malformations cause no issue but in approximately half of patients, these can be problematic. They can grow significantly causing a variety of symptoms including overlying skin discoloration, swelling and pain. Complications can ensue including infection, bleeding, blood clots, growth abnormality or joint problems at the affected body part. Although there is no cure for vascular malformations, sclerotherapy can improve your symptoms and their appearance.

The multidisciplinary team looking after you will have assessed your suitability for the procedure. You will have the opportunity to discuss the procedure and other options with the doctor beforehand, and decide whether you would like to proceed.

What are the possible risks of having sclerotherapy?

Sclerotherapy is a safe and effective procedure, but as with any medical procedure there are some risks and complications that can occur. Clinical staff consider both the risks and benefits when deciding what intervention is appropriate for you. A decision to proceed with sclerotherapy is taken when the benefits of it are thought to outweigh the risks.

The radiologist will explain the risks of sclerotherapy to you before the procedure. These include the following:

• There will be pain and swelling following the procedure. The pain should subside over a day or so but the swelling can be expected to last up to 14 days.
• Bleeding and bruising may occur.
• Injection site infection may occur and need antibiotic treatment.
• If the malformation is close to, or just under the skin, there is a small risk of skin blistering and ulceration. If this occurs, wound care may be required and the healing process will be more prolonged.
• There is a risk of permanent scarring or pigmentation changes at the procedure site.
• If a vascular malformation is close to a major nerve, it rarely can cause nerve damage. This is usually temporary; however, extremely rarely it can be permanent.
• Incomplete response or recurrence can occur which may require further treatment. Procedure failure occurs if it is deemed unsafe to proceed.

Contrast

Sclerotherapy may use contrast dye injection, and rarely, an allergic reaction may occur. A reaction may take the form of an itchy rash but very rarely, a severe allergic reaction can occur. The team are trained to monitor for contrast reactions and manage it accordingly.

If you have had a previous reaction to contrast, please let us know before the procedure, and we can put measures in place to minimise risk of another reaction.
Kidney damage related to contrast dye use can occur. This is often reversible but may require hospitalisation.

Radiation

Sclerotherapy uses x-ray radiation. Accumulated radiation exposure can pre-dispose to the development of certain cancers but the radiation dose that you get from sclerotherapy is small and the associated risks are low. Clinical staff ensure that the dose you receive is kept as low as necessary to aid your diagnosis or treatment.

Pregnancy

If you are in the early stages of pregnancy, there is a very small risk of x-rays harming your unborn child. If you think you could be pregnant, or you are trying to get pregnant, please tell us before your appointment. Individuals aged 10 to 55 years old will be asked to confirm their pregnancy status by the radiographer before the procedure and sign a form.

Are there any alternatives?

Vascular malformations can be managed with a combination of compression, sclerotherapy, laser, surgery, or a procedure called embolisation.

Your referrer has decided that sclerotherapy would be the most useful procedure in your case. The examination will help your referrer to assess you more fully and plan any further treatment that might be necessary. If you would like more information about alternative treatments, please speak to the doctor or health care professional managing your care.

Consent

We want you to be involved in all the decisions about your care and treatment. If you choose to go ahead, you will be asked to sign a consent form before proceeding. This confirms that you agree to have the procedure and understand everything involved. Students/trainees may be present during the examination but only with your verbal consent.

Please remember that you can ask the interventional radiologist any questions you have at any time before, during or after your scan.

Pre-assessment

An appointment with one of our pre-assessment nurses may be required prior to your procedure. They will carry out a pre-assessment health check and explain the procedure and answer any questions you may have.

At your pre-assessment visit you will be asked questions about your general health and some questions which are important for us to know so that we can prepare for your procedure and give you advice before attending. You may also have some blood samples taken.

It is important to let know if you have any of the following:

• Severe allergies?
• Have you had a previous adverse reaction to x-ray dye before?
• Asthma, which is poorly controlled?
• Renal impairment (poor kidney function)?
• Diabetes, which is treated with Metformin therapy?
• Are taking any anti-coagulants (blood thinners)?

Fasting is only needed if the procedure is planned to be done under sedation or general anaesthetic.

Please attend the appropriate department as stated on your appointment letter.

What happens during the procedure?

You will be asked to change into a hospital gown and a small cannula (thin tube) will be inserted in your arm. You will be brought to the Interventional suite in your bed, where you will be met by a team of nurses, a radiographer and an interventional radiologist. The procedure will be explained to you by the radiologist and you will be asked to sign a consent form. The Royal Victoria Hospital is a teaching hospital and as such university students may be in attendance, with your permission.

You will be helped to transfer onto the x-ray table and monitors attached to record heart rate and blood pressure. The procedure will most likely be carried out under local anaesthetic for adults (possibly with a light sedative) and general anaesthetic for children.

The skin overlying the vascular malformation will be wiped with antiseptic to clean it, then using ultrasound guidance a small needle will be placed into the vascular malformation. A small amount of x-ray dye is sometimes injected to confirm the needle is correctly positioned and to calculate the correct volume of sclerosing agent to inject. The liquid or foam sclerosing agent is injected and the procedure is finished. Sometimes it is not possible to place a needle in a safe position and the procedure has to be abandoned.

What happens after the procedure?

Once the procedure is completed you will return to the Day of Surgery Ward / Unit for nursing staff to monitor you post procedure and to check the treatment site. You can usually eat and drink normally, unless told not to. You will generally go home later that day.

If sedation was required, you will need to have someone to accompany you home, and stay with you for 24 hours.

A pre-sized compression garment is usually recommended after the procedure. Procedure outcome can take up to 3 months to become apparent.

What to do when you get home?

• Rest for the remainder of the day and do not drive or do strenuous exercise for 48 hours to give injection site time to heal
• You can resume normal activities 48hours after your procedure
• Have someone stay with you overnight
• Eat and drink normally
• Continue with your regular medication as usual, unless given special instructions
• You can shower 24hours after the procedure or bath 48hours after. The treatment site does not need to be covered
• If you have any concerns or if complications develop, please contact us for advice

Results

You may be able to discuss your procedure with the performing interventional radiologist once it is complete. The outcome of your intervention will be formally reported and communicated with your referring clinician, who may arrange follow-up if needed.

Usually, the results of sclerotherapy are clear to see. With standard sclerotherapy these results often take up to 3 months but in some cases may take up to 12 months.

Image sharing

Your images will be electronically stored on the hospital picture archiving system. This data can be accessed throughout the Belfast Health and Social Care Trust and other doctors and health care professionals who are directly involved in your care. The ability to share images and radiological reports will improve the safety and quality of your care by ensuring that the right information is available in the right place at the right time.

In order to improve our medical service, we may also use your data as anonymously as possible for internal audit and medical education. If you would prefer that your data is not used for these purposes, please inform a member of staff when you attend for your examination.

If your data is to be used for research, then a separate consent process will be used. You will be asked for your consent, should this be the case.

Contact us

We will be happy to answer any questions before or after your procedure and you can contact us on the number given on your appointment letter.

For procedures performed at the Royal Victoria Hospital:

Email InterventionRadRVH@belfasttrust.hscni.net
Tel: 028 9615 6661 Interventional Radiology Secretary RVH

For procedures at the Belfast City Hospital:

Email InterventionRadBCH@belfasttrust.hscni.net
Tel: 028 9504 1165, Interventional Radiology Secretary BCH

Further information can be accessed on the British Society of Interventional Radiology patient portal.

What is sclerotherapy?
Why does your child need sclerotherapy?
What are the risks of having sclerotherapy?
Contrast
Radiation
Pregnancy
Are there any other treatment options?
On the day of the procedure
Consent
What happens during sclerotherapy?
How long does it take?
What happens after the sclerotherapy procedure?
Aftercare following discharge
When will I get the sclerotherapy results?
Image sharing
Contact us

What is sclerotherapy?

Sclerotherapy, or “sclero” for short, is used to treat vascular malformations that are growths of blood vessels present at birth. These tend to grow slowly and can cause a variety of symptoms which may benefit from treatment.

Sclerotherapy is done using image guidance by an interventional radiologist. Most often sclerotherapy is performed alone or in combination with laser or embolisation. Treatment is carried out under general anaesthetic for children.

A doctor inserts a needle into the skin and injects a special liquid called a sclerosant into the abnormal blood vessel. This makes the blood vessel shrink. Sometimes the malformations can enlarge again and sclerotherapy may be done in stages.

Figure 1:
(A) Vascular malformation before intervention. (B) Shrunken vessels after intervention.

Why does your child need sclerotherapy?

Some vascular malformations cause no issue but in approximately half of patients, these can be problematic. They can grow significantly causing a variety of symptoms including overlying skin discoloration, swelling and pain. Complications can ensue including infection, bleeding, blood clots, growth abnormality or joint problems at the affected body part. Although there is no cure for vascular malformations, sclerotherapy can improve your symptoms and their appearance.

What are the risks of having sclerotherapy?

Sclerotherapy is a safe and effective procedure, but as with any medical procedure there are some risks and complications that can occur. The risks of general anaesthetic will be discussed by your child’s anaesthetist beforehand separately.

The following are risks of sclerotherapy:

• Pain and swelling following the procedure. The pain should subside over a day or so, but the swelling can be expected to last up to 14 days.
• Bleeding and bruising may occur.
• Injection site infection may occur and need antibiotic treatment.
• If the malformation is close to, or just under the skin, there is a small risk of skin blistering and ulceration. If this occurs, wound care may be required and the healing process may take longer.
• Permanent scarring or pigmentation changes at the procedure site may occur.
• If a vascular malformation is close to a major nerve, it rarely can cause nerve damage. This is usually temporary; however, extremely rarely it can be permanent.
• Incomplete response or recurrence can occur which may require further treatment.
• The procedure may not be completed if the team feels it is unsafe to continue.

Contrast

Sclerotherapy may use x-ray contrast dye injection, and rarely, an allergic reaction may occur. A reaction may take the form of an itchy rash but very rarely, a severe allergic reaction can occur. The team are trained to monitor for contrast reactions and manage it accordingly.

If your child has had a previous reaction to contrast, please let us know before the procedure, and we can put measures in place to minimise risk of another reaction.
Kidney damage related to contrast dye use can occur. This is often reversible but may require hospitalisation.

Radiation

Sclerotherapy uses X-ray radiation. Accumulated radiation exposure can pre-dispose to the development of certain cancers but the radiation dose that you get from sclerotherapy is small and the associated risks are low. Clinical staff ensure that the dose you receive is kept as low as necessary to aid your diagnosis or treatment.

Pregnancy

It is a legal requirement that children aged 10 years or older will be asked about their periods and any possibility that they could be pregnant. Please inform the Radiology Department if your child’s period falls outside of its normal cycle on the appointment date, as it may need to be rescheduled.

Are there any other treatment options?

Vascular malformations can be managed with a combination of compression, embolisation, sclerotherapy, laser or surgery. If you would like more information about these alternative options, please speak to the doctor or health care professional managing your child’s care.

Your referrer has decided that sclerotherapy would be the most useful treatment for your child. A clinical examination will help the referrer assess and plan any further treatment that may be necessary.

On the day of the procedure

Please attend the appropriate department as stated on your appointment letter with your child. Ward staff will help to prepare your child for their procedure; this will include completing a theatre checklist and taking a blood sample. Play specialists are available to help your child understand what is going to happen during the procedure. The Royal Victoria Hospital and Royal Belfast Hospital for Sick Children are teaching hospitals and as such, university students may attend, with your permission.

Please ensure to highlight to the team if your child has any of the following:

• A history of severe allergy (or anaphylaxis)?
• A previous adverse reaction to x-ray dye?
• Difficult to treat asthma?
• Renal impairment (poor kidney function)?

Your child should not eat or drink anything for 6 hours before the procedure.

Consent

We want you involved in all the decisions about your child’s care and treatment. Before the procedure, your child’s Radiologist will discuss any risks with you and answer your questions. If you choose to go ahead, you will be asked to sign a consent form. This confirms that you agree to your child having the procedure and understand everything involved.

What happens during sclerotherapy?

Your child will be transferred onto the X-ray table. The anaesthetist will help your child go to sleep, you can be present to comfort your child until they are asleep. Monitors will be attached to record heart rate and blood pressure.

The procedure is performed under sterile conditions and the interventional radiologist will wear a sterile gown and gloves to carry out the procedure. The child will be positioned comfortably to allow for suitable access to the area requiring treatment. The skin will be cleaned with antiseptic, and numbed with local anaesthetic. Using ultrasound guidance, a small needle will be placed accurately into the malformation. Once in position, a small amount of x-ray dye will be injected to assess the malformation, the sclerosant will then be injected.

Once the procedure is completed a dressing will be applied and the use of a compression garment may also be required.

How long does it take?

Each treatment will take approximately one to two hours and sometimes longer depending on the complexity of the malformation. Whilst we try to accommodate all patients at their appointed time, occasionally emergencies arise which may delay your child’s procedure. If your child’s procedure is cancelled due to an emergency, it will be reappointed for the next available date.

What happens after the sclerotherapy procedure?

Once the procedure is completed, your child will return to the ward for nursing staff to monitor them post procedure. Your child will generally remain in bed for 4 hours and can usually eat and drink normally, unless told not to. Most children are able to go home later that day.

Aftercare following discharge

You will be given information on caring for your child at home. The areas that were injected are normally swollen for one week and bruised for two to three weeks following the procedure. The skin close to the abnormal blood vessel may blister or be sore.

When will I get the sclerotherapy results?

You may be able to discuss your procedure with the performing interventional radiologist once it is complete. The outcome of your intervention will be formally reported and communicated with your referring clinician, who may arrange follow-up if needed.

Usually, the results of sclerotherapy are clear to see. With standard sclerotherapy these results often take up to 3 months but in some cases may take up to 12 months.

Image sharing

Images will be electronically stored on the hospital picture archiving system. This data can be accessed throughout the Belfast Health and Social Care Trust and by other doctors and health care professionals directly involved in your child’s care. The ability to share images and radiological reports will improve the safety and quality of care by ensuring the right information is available in the right place at the right time.

Also to improve our service, we may also use your child’s data for internal audit and medical education. This is completely anonymous. However, if you do not want these details used, please inform the hospital team.

You will also be asked if you want your child’s data used for research. Giving permission involves a separate consent process.

Contact us

If you have any queries, we will be happy to answer any questions before or after your child’s procedure and you can contact us on the number given on your appointment letter.

For procedures performed at the Royal Victoria Hospital:

Email InterventionRadRVH@belfasttrust.hscni.net
Tel: 028 9615 6661, Interventional Radiology Secretary RVH

For procedures performed at the Royal Belfast Hospital for Sick Children:

Tel: 028 9615 0289, Childrens X-ray Reception Desk.

Further information can be accessed on the British Society of Interventional Radiology patient portal.