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Guideline No: 0/C/11:8045-01:00 Guideline: Intrathecal Baclofen: Administration and Patient Management INTRATHECAL BACLOFEN:
ADMINISTRATION AND PATIENT
MANAGEMENT
• Children with cerebral palsy often have significant movement disorders such as spasticity and dystonia that interfere with daily care and participation in life. • Baclofen acts to suppress skeletal muscle spasms and reduce muscle tone & spasticity. • Intrathecal (into the CSF around the spinal cord) administration enables baclofen delivery directly to the site of action, allowing for smaller doses with fewer systemic side effects. • Intrathecal baclofen (ITB) therapy is offered to selected patients who are not well- • The ITB test-dose procedure is performed to assess a child’s response to treatment and is done prior to the decision to proceed to a pump implant. • Staff involved in the care of patients having an ITB test-dose should be aware of possible baclStandard escalation of care processes, including Clinical Emergency Response System (CERS) should be followed. • If overdose is thought to occur, consideration should be given for the child to be specialled (1:1 Nurse: Patient) and for the Bed Manager/After Hours Nurse Manager (AHNM) to be contacted to arrange admission. This practice guideline covers the test-dose process, but it is the intention to expand the document to include all ITB management. This document reflects what is currently regarded as safe practice. However, as in any clinical situation, there may be factors which cannot be covered by a single set of guidelines. This document does not replace the need for the application of clinical judgement to each individual presentation. Date of Publishing: 12 August 2011 4:15 PM K:\CHW P&P\ePolicy\Aug 11\Intrathecal Baclofen - Administration and Patient Mgt.docx This Guideline may be varied, withdrawn or replaced at any time. Guideline No: 0/C/11:8045-01:00 Guideline: Intrathecal Baclofen: Administration and Patient Management • All clinical staff (medical, nursing and allied health) who are involved in the administration of ITB and subsequent patient management should read this document. • Sydney Children’s Hospital Network (Westmead Campus) [The Children’s Hospital at Westmead (CHW)] is the state-wide service for children being considered for ITB therapy. At this stage, all paediatric ITB related procedures are only performed at CHW. • Training/Assessment Required – The procedure outlined in this practice guideline
may only be carried out by Kids Rehab medical staff who have been trained in the procedure. This document reflects what is currently regarded as safe practice. However, as in any clinical situation, there may be factors which cannot be covered by a single set of guidelines. This document does not replace the need for the application of clinical judgement to each individual presentation. Date of Publishing: 12 August 2011 4:15 PM K:\CHW P&P\ePolicy\Aug 11\Intrathecal Baclofen - Administration and Patient Mgt.docx This Guideline may be varied, withdrawn or replaced at any time. Guideline No: 0/C/11:8045-01:00 Guideline: Intrathecal Baclofen: Administration and Patient Management Date of Publishing: 12 August 2011 4:15 PM K:\CHW P&P\ePolicy\Aug 11\Intrathecal Baclofen - Administration and Patient Mgt.docx This Guideline may be varied, withdrawn or replaced at any time. Guideline No: 0/C/11:8045-01:00 Guideline: Intrathecal Baclofen: Administration and Patient Management Background
Baclofen is a derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). As a GABA agonist baclofen binds to GABA receptors in the spinal cord, increasing the inhibitory action to suppresses skeletal muscle spasms and reduce muscle tone and spasticity1. Baclofen crosses the blood brain barrier poorly when given enterally and thus it may not reach spinal cord receptors at sufficient concentrations to have therapeutic action without causing side effects2. Intrathecal administration enables baclofen delivery directly to the site of action, allowing for smaller doses with fewer systemic side effects. An intrathecal baclofen (ITB) pump is a programmable drug infusion system that consists of an implanted pump, and an intrathecal catheter. The pump is available with reservoir sizes of either 20mL or 40mL and is filled accordingly with baclofen. An external programmer is used to change dosing based on specific goals of treatment. The dose can be prescribed to deliver a continuous infusion over a 24 hour period or prescribed at different scheduled doses throughout a 24 hour period3. Treatment
Best established treatment effect of ITB is in patients with severe spasticity in the lower limbs, commonly found in children with cerebral palsy classified as level IV–V according to the Gross Motor Function Classification System (GMFCS)4. There is some evidence that ITB is effective for treating generalised dystonia5. Expert opinion and consensus on appropriate treatment guidelines indicates selection of patients for ITB should follow a consistent approach6. This starts with the child having a comprehensive multidisciplinary team assessment to confirm presence of spasticity/dystonia, management of factors that may be contributing to tone and care issues and a trial of oral medications. Screening for a response to this therapy can be tested before a pump is implanted by way of a test-dose, performed as a lumbar puncture and injection of a bolus dose of baclofen1. This guideline currently outlines the test-dose procedure and potential risks of drug overdose but the document will be expanded to include other aspects of ITB management. Intrathecal baclofen therapy has known risks and complications7, including device related problems from the pump and catheter which can cause baclofen withdrawal or overdose. If overdose is thought to occur (refer, consideration should be given for the chilfor the Bed Manager/After Hours Nurse Manager (AHNM) to be contacted to arrange admission. • Altered level of consciousness • Respiratory depression Date of Publishing: 12 August 2011 4:15 PM K:\CHW P&P\ePolicy\Aug 11\Intrathecal Baclofen - Administration and Patient Mgt.docx This Guideline may be varied, withdrawn or replaced at any time. Guideline No: 0/C/11:8045-01:00 Guideline: Intrathecal Baclofen: Administration and Patient Management Intrathecal Baclofen Test-dose Processes
Pre-admission – Clinic Process
1. Children are initially assessed in the Cerebral Palsy and Movement Disorder Clinic by
the ITB team [Doctor, Clinical Nurse Consultant (CNC), Occupational Therapist, Physiotherapist, and Social Worker]. If a child is thought to be suitable, an admission date is discussed and agreed to with the team and family. Further education and written information or a DVD is given to the family at this time. 2. The doctor seeing the child in clinic is responsible to:
i. Complete the Hospital Admission Forms.
ii. Write an outpatient script for the baclofen required for the test dose:
2 x ampoules of 50 micrograms/mL.
A request for blunt needle filters should be included on the script.
(The CNC will collect the script prior to admission date and have available for
test dose date.)
3. Suggested intrathecal dosing guideline:
Children > 18kg – 50, 75 or 100 micrograms, depending of severity of spasticity1. Children < 7 years / < 18kg - 50-75 micrograms Children > 7 years / > 18 kg – 50-100 micrograms In some cases, children may be admitted for a continuous intrathecal infusion starting 200 micrograms/day and increase (↑) by 50 micrograms every 8 hours until effect occurs1, 8. 4. A weaning regimen of oral baclofen is given to the family in the assessment clinic
to commence approximately 2 weeks prior to the admission date, as per Rehab Consultants’ weaning protocol. Consideration should be given to other drugs that may influence the outcome of the Lumbar Puncture procedure (e.g. anticoagulants). Consultation with relevant sub-specialty team may be required as part of this decision making. 5. ITB therapy team contacts the child’s community therapists to discuss possible goals of
6. Families are contacted by the CNC prior to the admission date to discuss progress of
baclofen weaning. If necessary, oral diazepam may be needed to assist spasm control. Date of Publishing: 12 August 2011 4:15 PM K:\CHW P&P\ePolicy\Aug 11\Intrathecal Baclofen - Administration and Patient Mgt.docx This Guideline may be varied, withdrawn or replaced at any time. Guideline No: 0/C/11:8045-01:00 Guideline: Intrathecal Baclofen: Administration and Patient Management At Admission
Children are usually admitted by the Rehab Resident on a Wednesday evening. A review of the child is performed at this time by the CNC and Registrar/Consultant performing: • A medical physical assessment, • Confirming fasting times and • To mark the spine for application of EMLA cream. The ITB test dose amount is also confirmed and baclofen dose written on the patients medication chart with a note that the drug has already been ordered from Pharmacy. Intrathecal Baclofen Test-dose Procedure
1. The child is to be fasted from 4.30am. Discuss with family and nursing staff and
document in patient notes. Medications a child usually takes should be given. This may include a small dose of enteral baclofen. 2. Ward staff are to have available:
3. At 7.30am Ward nursing staff are to apply local anaesthetic cream (e.g. EMLA® or L-M-
X®) and a clear adhesive patch (e.g. Tegaderm®) on the pre-marked area on patient’s spine. 4. At 7.45am the ITB Physiotherapist and Occupational Therapist perform a
comprehensive assessment that includes, Barry Albright Dystonia Scale, Modified Ashworth Scale, modified Tardieu scale on muscle tone, range of movements, video-recording of transfers and dressing procedures especially if these are goal areas. The assessment procedure will be video-recorded for future reference and discussion with families. 5. The ITB test dose procedure is performed in a procedural room with monitoring
equipment. Suction and nitrous oxide should also be available: The CNC is available to administer the nitrous gas and a ward RN should be available to assist with the procedure for monitoring and positioning the child during the procedure. 6. Procedure commences 8.30am. The procedure may only be carried out by Kids Rehab
medical staff who have been trained in the procedure. 7. Follow when performing an LP. In addition
Date of Publishing: 12 August 2011 4:15 PM K:\CHW P&P\ePolicy\Aug 11\Intrathecal Baclofen - Administration and Patient Mgt.docx This Guideline may be varied, withdrawn or replaced at any time. Guideline No: 0/C/11:8045-01:00 Guideline: Intrathecal Baclofen: Administration and Patient Management i. Draw up Lignocaine for local anaesthetic in a 2mL syringe to distinguish it
from the syringe containing the baclofen. Ensure that the local anaesthetic lignocaine is not injected in to the epidural space. Discard this syringe after lignocaine is administered. ii. Draw up the baclofen for intrathecal administration in a 5mL syringe;
performed by the doctor performing the test-dose procedure. The baclofen is to be double checked and signed as per medication orders. Syringe should be marked with label provided by Pharmacy. Procedure Following Test-dose
1. The child should lie flat in bed for 2 hours after the injection to reduce risk of CSF and
baclofen leak. NB. These instructions vary to the LP procedure listed above. 2. Observations A full set of observations should be performed 15 minutely for 1st hour
then hourly for 6 hours or until patient is discharged. These are recorded on the age-appropriate NSW Health Standard Paediatric Observation Chart. 3. The effects of baclofen peaks at 2-4 hours post-injection then gradually wears off by 8
4. Child should be observed for possible reactions to baclofen that may indicate overdose
(refer to which includes altered level of consciousness such as drowsiness
or lethargy, hypotension, or changes in respiratory status. In addition, please notify the
medical team if the child hasn’t voided following the test dose.
5. Kids Rehab Team assessments (including muscle tone) are performed at 1, 2, 4 & 6
hours post-procedure. A reduction in the Barry Albright Dystonia Scale of at least 25% and/or a change in the Modified Ashworth score are considered a positive test dose response. Achievement of family goals is also considered. 6. Once the child has tolerated sitting up after the procedure they can usually also have
access to their wheelchair however this will be led by the therapy team. Transfers into and out of bed often gives the team important information about the child’s response to the intrathecal baclofen injection. 7. Prior to discharge, the Kids Rehab Team meet with the family to discuss test dose
response, follow-up plans and are given a regimen to restart oral baclofen if appropriate. 8. Children are discharged in the evening once the Kids Rehab Team has assessed if the
ITB effects have worn off and that the child is safe. If there are concerns about the child’s recovery from the procedure, they may need to be admitted overnight. Baclofen Test-dose Overdose
Baclofen overdose is characterised by altered consciousness and respiratory depression and may be evidenced throughout the continual monitoring of the patient as per the observations iabove until the ITB effects have worn off. Date of Publishing: 12 August 2011 4:15 PM K:\CHW P&P\ePolicy\Aug 11\Intrathecal Baclofen - Administration and Patient Mgt.docx This Guideline may be varied, withdrawn or replaced at any time. Guideline No: 0/C/11:8045-01:00 Guideline: Intrathecal Baclofen: Administration and Patient Management 1. If the child enters the Yellow Zone Criteria (or staff or a family member is concerned) on the NSW Health Standard Paediatric Observation Chart, a Clinical Review by the Rehabilitation Registrar (page 7181) should be initiated promptly. 2. If child deteriorates into the Red Zone (or there is a serious concern by any staff or family member), in line with standard procedure, escalation to a Rapid Response Call or an arrest call should be made immediately. 3. If overdose has occurred, consideration should be given for the child to be specialled (1:1 Nurse: Patient) as per the One to One Nursing Care of Patients (Specialling)
policy:.
References
1. Albright A.L. & Ferson S.S. Intrathecal baclofen therapy in children, Neurosurgical Focus, 2006. 21(2): 2. Butler C. & Campbell S. Evidence of the effects of intrathecal baclofen for spastic and dystonic cerebral palsy, Developmental Medicine & Child Neurology, 2000. 42(9), 634-645 3. Krach L.E., Kriel R.L. & Nugent, A.C. Complex dosing schedules for continuous intrathecal baclofen infusion, Pediatric Neurology, 2007. 37(5), 354-359 4. Dan B., Motta F., Vles J.S.H., et al. Consensus on the appropriate use of intrathecal baclofen (ITB) therapy in paediatric spasticity, European Journal of Paediatric Neurology, 2009. 14(1), 19-28 5. Albright A.L., Barry M.J., Shafton D.H. & Ferson S.S. Intrathecal baclofen for generalised dystonia, Developmental Medicine & Child Neurology, 2001. 43(10), 652-657 6. Ridley B. & Rawlins P.K. Intrathecal Baclofen Therapy: Ten Steps Toward Best Practice, Journal of Neuroscience Nursing, 2006. 38(2), 72-82 7. Kolaski, K., & Logan, L.R. (2007). A review of the complications of intrathecal baclofen in patients with cerebral palsy, NeuroRehabilitation, 22(5), 383-395 8. Hoving, M.A., van Raak, E.P.M., Palmans, L.J., Sleypen, F.A.M., & Vles, J.S.H. (2007). Intrathecal baclofen in children with spastic cerebral palsy: a double-blind, randomized, placebo-controlled, dose-finding study, Developmental Medicine & Child Neurology, 49(9), 654-659 Copyright notice and disclaimer:
The use of this document outside The Children's Hospital at Westmead (CHW), or its reproduction in whole or in part, is subject to acknowledgement that it is the property of CHW. CHW has done everything practicable to make this document accurate, up-to-date and in accordance with accepted legislation and standards at the date of publication. CHW is not responsible for consequences arising from the use of this document outside CHW. A current version of this document is only available electronically from the Hospital. If this document is printed, it is only valid to the date of printing. Date of Publishing: 12 August 2011 4:15 PM K:\CHW P&P\ePolicy\Aug 11\Intrathecal Baclofen - Administration and Patient Mgt.docx This Guideline may be varied, withdrawn or replaced at any time.

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