What is Intrathecal Baclofen® (Lioresal)? Baclofen, is a medicine used for tight muscles (spasticity). It can help the muscles relax. It comes in pill form and intrathecal form.
• Intrathecal means it is given directly into the spinal fluid. The spinal fluid surrounds the spinal cord. • Giving it this way often helps the medicine work better and have fewer side effects. Why does my child need intrathecal Baclofen ? Spasticity is muscle tightness or stiffness. Stiffness can occur when nerve signals from the spinal cord or brain does not go to the muscles in the right way. This may happen in children with cerebral palsy, spinal cord injury, muscular dystrophy and other medical problems. Baclofen does not cure your child’s problem. It can help to improve your child’s quality of life and problems caused by the spasticity. Some changes you may see in your child include improvement with:
• Range of motion, flexibility and movement
• Muscle spasms • Pain control Why use this method instead of medicine taken by mouth? With the intrathecal method, your child can have fewer side effects, such as less:
• Stomach upset and nausea • Drowsiness
How is the medicine given? The medicine is usually given by a pump. The pump is about the size of a large donut. It is placed just under the skin in your child’s lower abdomen (tummy) during surgery. The pump holds the medicine. The pump:
• Gives your child Baclofen in very small doses around the clock. It goes from
the pump into the spinal fluid through a small plastic tube called a catheter.
• Gives your child the correct dose of Baclofen based on his needs.
• Is controlled by a computer. • Has beeps and alarms that go off when it is time to have the medicine level
• Runs on batteries that usually last for 7-8 years.
• Needs to be refilled with medicine every 1-6 months based on your child's daily
In case of an urgent concern or emergency, call 911 or go to the nearest emergency room right away. This is general information and is not specific medical advice for your child. These instructions contain some common facts about your child’s medicine. They do not describe all uses, side effects and safety information. Always consult your child’s doctor or other healthcare provider if you have any questions or concerns about the care or health of your child. A Children’s Healthcare of Atlanta pe
diatric advice nurse is available 24 hours a day at 404-250-KIDS.
Medication l PFEI 146 / 10.06 / Baclofen Pump
Baclofen test dose What is a Baclofen test dose? A test dose is given to see how your child responds to Baclofen. If your child’s muscles become less stiff after the test dose, your child may be able to receive the pump. What will the test dose be like?
• The test dose may be done in radiology or in a procedure room depending on your child’s needs and
• An overnight stay may or may not be required depending on your child’s needs and your doctor’s
• Your child will have a numbing cream put on his back. This helps decrease pain at the injection site.
• The injection (shot) is given in his lower back using a small syringe. It is given below the level of the
• Once the needle is in place, a small dose of Baclofen is given. • The needle is then removed and an adhesive bandage is applied.
• During this time, our staff will check your child’s vital signs (heart rate, blood pressure and breathing).
What happens after the test dose? Your child’s physical therapist will check his muscles for spasticity.
• Keep your child in the bed until he is checked by a physical therapist or other staff member.
• Your child may have some muscle looseness. Keep your child’s side rails up and request help from staff
if you need to get your child out of bed.
• The effects of the medicine may not be seen for 30 minutes to 1 hour. • The greatest effect can be seen about 4 hours after the injection. • The effect may begin to wear off in 6-8 hours after the injection. Your child’s spasticity will return to the
same as it was before the injection was given.
When do I get the results of the test dose? • The test dose is a screening test only. It will help to show if your child’s spasticity responds to Baclofen.
• Your child’s doctor may be able to tell you before your discharge their opinion of the test dose. • Some children do not respond to the first test dose. In this case, his doctor may give a second test dose
• Your child’s muscles may loosen only slightly or they may relax so much that he cannot use them. This
During the test dose, your child may have some or all of these temporary effects:
• Nausea or vomiting • Drowsiness • Overly loose muscles
• Headaches • Dizziness If your child has any of these, call your child’s nurse right away using the nurses call bell. In case of an urgent concern or emergency, call 911 or go to the nearest emergency room right away. This is general information and is not specific medical advice for your child. These instructions contain some common facts about your child’s medicine. They do not describe all uses, side effects and safety information. Always consult your child’s doctor or other healthcare provider if you have any questions or concerns about the care or health of your child. A Children’s Healthcare of
Atlanta pediatric advice nurse is available 24 hours a day at 404-250-KIDS. Medication l PFEI 146 / 10.06 / Baclofen Pump
Baclofen Pump, continued When should I call the doctor? Once you are discharged home, call the doctor if your child has:
• Nausea or vomiting. • Redness, swelling, pus, drainage, or bad smell at the injection site. • Fever over 1010F that is not relieved by acetaminophen (Tylenol® or other less costly store brand).
• Problems staying awake. • New rash or itching. • Increased muscle weakness that is getting worse. Call the doctor who will be managing your child’s pump for a follow up appointment if you do not already have one scheduled.
Baclofen® pump
After the test dose, if the Baclofen seems to work for your child, his doctor may schedule him for a pump implant. The implant is done in surgery.
• The pump is placed just under the skin while your child is under anesthesia
• The pump is programmed to give your child medicine based on his
• We will give you instructions to follow before the implant can be done. They will tell you:
- When your child needs to stop eating and drinking. His stomach needs to be
empty to help prevent vomiting and choking during surgery.
How do I take care of my child after we go home? Once you go home, have your child:
• Lie as flat as possible for 2 to 3 days to decrease nausea, vomiting and spinal headaches. • When moving your child from place to place- do not allow him to put his arms around your neck to
transfer. This technique can place too much pressure on the pump.
• Change your child’s position often to avoid developing pressure ulcers (bed sores). • When changing clothes, do not raise his arms above his head. It may be best to have your child wear
• Roll from side to side when changing his diaper instead of lifting his legs. • If your child uses a wheelchair, call his physical therapist or orthotist before you go home from the
hospital if any changes are needed to the chair.
Have your child avoid these things for 4 to 6 weeks depending on his doctor’s preference:
• Bending at the waist. • Reaching above his head. • Bending forward or backward.
• Sleeping on the incision before the staples are removed • Movement that can cause stress on the incision. In case of an urgent concern or emergency, call 911 or go to the nearest emergency room right away. This is general information and is not specific medical advice for your child. These instructions contain some common facts about your child’s medicine. They do not describe all uses, side effects and safety information. Always consult your child’s doctor or other healthcare provider if you have any questions or concerns about the care or health of your child. A Children’s Healthcare of
Atlanta pediatric advice nurse is available 24 hours a day at 404-250-KIDS. Medication l PFEI 146 / 10.06 / Baclofen Pump
Baclofen Pump, continued How do I care for my child’s incision? Keep the skin around the pump clean and dry. Check the incisions every day for:
• Redness • Puffiness • Drainage or pus
• Bad smell Take his temperature each morning and evening.
• If his temperature is more than 101.5°F and is not relieved by acetaminophen (Tylenol® or other less
costly store brand) call your child’s doctor right away.
• Keep the incision clean and dry. • Do not allow the pump to go under water for 4 weeks. This includes taking a tub bath and swimming.
• Do not let anything rub against the incision such as diapers, belts and clothing. Keep seatbelts off the
What kind of follow-up care is needed?
• Bring your child in for all follow-up appointments. • You will be given an Emergency Baclofen Card. Keep this card with you at all times. If you need to
take your child to an emergency room, give the emergency room staff the card as soon as you arrive.
What other care is needed? Travel and vacations:
• Plan ahead. Have your child’s pump re-filled before your vacation. • The implant may set off metal detectors at the airport. Give airport security your child’s Emergency
Baclofen Card and Implanted Device Card when you travel.
• Your child cannot use deep heat therapy, whirlpools or Jacuzzis.
• Your child cannot take part in activities that cause extreme changes in air pressure like scuba diving and
• Tell your child’s doctors and dentists about the pump so they can adjust medicines and treatments. • Talk with your child’s doctor about any other medicines that he may be taking. This includes over-the-
counter medicines, herbs, supplements and vitamins.
• Do not stop giving your child any of his medicines used to decrease spasms all of a sudden. • Let your child’s doctor know if he is having other health problems. Problems such as urinary tract
infections, constipation, and wounds may cause spasticity to be worse.
• Keep your child’s pump filled with medicine by keeping your child’ appointments. • Call your child’s doctor before your child has an MRI. In case of an urgent concern or emergency, call 911 or go to the nearest emergency room right away. This is general information and is not specific medical advice for your child. These instructions contain some common facts about your child’s medicine. They do not describe all uses, side effects and safety information. Always consult your child’s doctor or other healthcare provider if you have any questions or concerns about the care or health of your child. A Children’s Healthcare of
Atlanta pediatric advice nurse is available 24 hours a day at 404-250-KIDS. Medication l PFEI 146 / 10.06 / Baclofen Pump
Baclofen Pump, continued When should I call my child’s doctor? Call your child’s doctor right away or proceed to the nearest emergency room if your child has: Symptoms of too much (an overdose) Baclofen:
• Problems staying awake • Dizziness • Lightheadedness
• Seizures • Problems breathing • Drowsiness • Coma Symptoms of too little Baclofen or underdose
• New rash or itching • Increased spasticity that is getting worse • Fever over 101 degrees
• Muscle ridgidty • Altered mental status How can I help make sure my child gets the right dose of his medicine? You can help your child get the right dose of Baclofen when you:
• Keep all of your refill appointments. • Know the alarms and alerts on your pump device. If your pump alarms, call your doctor right away. • Know the signs and symptoms of an overdose and underdose.
• Follow the instructions given to you carefully. If your child moves around too much after surgery, the tube that carries the medicine can become loose. This can lead to underdose or sudden withdrawal of the medicine. Pump Alarms What does the alarm mean? If your child’s pump ‘beeps’ or alarms it usually means:
• The medicine needs to be refilled, or • There is a problem with the pump. What do I do if the pump alarms? Any alarm needs attention right away. It could mean that the medicine is no longer flowing from the pump into the spinal canal.
• If the pump reads Memory Error, contact the Medtronic Technical Services number. • If this happens, call the doctor managing your child’s pump right away. • After you call the doctor, go to the nearest Emergency Room right away.
• Take the Emergency Baclofen Card with you.
In case of an urgent concern or emergency, call 911 or go to the nearest emergency room right away. This is general information and is not specific medical advice for your child. These instructions contain some common facts about your child’s medicine. They do not describe all uses, side effects and safety information. Always consult your child’s doctor or other healthcare provider if you have any questions or concerns about the care or health of your child. A Children’s Healthcare of
Atlanta pediatric advice nurse is available 24 hours a day at 404-250-KIDS. Medication l PFEI 146 / 10.06 / Baclofen Pump
Ministry of Environment & Forests Northern Regional Office Chandigarh DATA SHEET Project Type: Industry (Bulk Drugs) Name of the Project: Bulk Drugs by M/s Coral Drugs Pvt Ltd. Clearance letter (s)/ O.M No. & J-11011/135/2003-IA II (I) dt. 17.2.2006 4. Location: Address for correspondence: Chief Engineer (with Pin Code/ Tel M/s Coral Drugs Pv
SUMMARY. This article reports on two research projects and argues that current medication management research and practice does not represent the complexity of community-based psychotropic treatment. Ethnographic findings are used to demonstrate that a social grid of man- agement exists to negotiate medication ‘effect’ interpretation. Anthropo- logical and semi-structured interview data are