Intrathecal cytotoxic chemotherapy: administration via a lumbar puncture or Ommaya reservoir

The purpose of this guideline is to provide guidance about intrathecal cytotoxic chemotherapy administration via a lumbar puncture or Ommaya reservoir at Great Ormond Street Hospital (GOSH).

Note: While this guideline refers to the ‘child’ throughout, all activities are applicable to young people.

Introduction

This must be read in conjunction with the GOSH Operational Policy for the prescribing, dispensing, supply and administration of intrathecal and intrareservoir cytotoxic injections (GOSH 2016), and the updated national guidance on the safe administration of intrathecal chemotherapy (Department of Health 2008).

Cytotoxic intrathecal medication can only be administered by injection through an Ommaya shunt reservoir or by performing a lumbar puncture (Dougherty and Lister 2011).

Only methotrexate, cytarabine (Cytosine arabinoside, Ara-C) may be administered via the intrathecal route. Intrathecal hydrocortisone is often given at the same time as intrathecal methotrexate and cytarabine (GOSH 2016).

Cytotoxic intrathecal medication must only be administered by a suitably trained and authorised doctor whose name is on the GOSH Intrathecal Register.

The GOSH Intrathecal Register document names all staff involved in the clinical screening, final checking, dispensing, delivering, checking and administration of intrathecal chemotherapy. Paper copies of the register are kept in all areas where intrathecal chemotherapy is prescribed and administered. It is also available electronically.

Refer to the specific national and local guidelines that exist in relation to administration of cytotoxic intrathecal medication (GOSH 2016).

It is the responsibility of the individuals on the GOSH Intrathecal Register to ensure that any colleagues they involve in the process are on the register for the task in question (GOSH 2016).

All nursing staff should receive training in the risks associated with the administration of cytotoxic intrathecal chemotherapy. This should be appropriate to their level of involvement in the prescribing, verification, handling, preparation and administration of intrathecal chemotherapy (GOSH 2016).

Intrathecal chemotherapy must be issued by pharmacy at a different time from intravenous chemotherapy (GOSH 2016).

Ensure the intrathecal medication prescribed is compatible with this route of administration (GOSH 2016).

Intrathecal cytotoxic medication must be prescribed on a designated cytotoxic intrathecal chemotherapy drug chart, either by hand or by using Chemocare® (GOSH 2016).

Refer to hospital prescription guidelines. The medication and route of administration, 'INTRATHECAL', must be clearly written in full block capitals on the chart (GOSH 2016).

Intrathecal and intrareservoir chemotherapy doses will be dispensed in syringes which will not connect with intravenous luer connectors (National Patient Safety Agency (NPSA) /2009/PSA004A). (Rationale 1).

All intrathecal chemotherapy doses must be packed individually and separately from all other drugs, in a specially designated intrathecal chemotherapy bag. The outer bag must be labelled with the patient's name, ward and the words ‘for intrathecal use only' (GOSH 2016).

Contra-indications of the medicine (intrathecal chemotherapy):

  • nausea and vomiting
  • altered neurological status
  • infection
  • arachnoiditis (inflammation of arachnoid lining caused by infection) (Killeen et al 2012, Bogod 2012). The arachnoid layer is one of the three layers of the brain and spinal cord
  • headache
  • reduced white and red cell blood count

Preparation of equipment

  • medication formulary
  • treatment protocol
  • patient's medical notes with current dated treatment protocol
  • manufacturer's drug information (if required)
  • intrathecal medication and prescription
  • sterile dressing pack
  • alcohol-based antiseptic ChloraPrep®, 2% chlorhexidine in 70% isopropyl alcohol*
  • lumbar puncture needle (specifically designed needle that will not connect with intravenous syringes) (NPSA/2009/PSA004A) (Rationale 1)
  • sterile gauze squares
  • Op-site® spray or similar
  • sterile gloves 
  • apron
  • sterile field

*2% chlorhexidine gluconate in 70% isopropyl alcohol should not be used on the skin of pre-term infants under 35 weeks gestational age. It can be used with caution in children under two months of age. However, if there is any evidence of skin reaction in this age group, discontinue its use and consult the following for further advice:

  • Tissue viability CNS.
  • Vascular Access Team.

Alternative antiseptic solutions:

  • Povidone-iodine 10% (aqueous)
  • 0.5% chlorhexidine gluconate in 70% isopropyl alcohol.

Performing the procedure: general principles

Intrathecal medication must only be administered by a suitably trained doctor (GOSH 2016).

Intrathecal chemotherapy must only be given within working hours (between 8.30am - 5.30pm) (GOSH 2016).

Intrathecal chemotherapy to be administered with general anaesthesia, local anaesthesia or Entonox® must only be administered in a designated area on a designated haematology/oncology list (GOSH 2016) (Rationale 2).

At GOSH these designated areas are:

  • general anaesthetic procedure room on Safari Day Care
  • main VCB theatres
  • Morgan Stanley theatres

If the location of a procedure changes from one designated area to another, a pharmacist must move the chemotherapy (Department of Health 2008, GOSH 2016) (Rationale 3).

If for any reason intrathecal chemotherapy cannot be given in a designated list, the patient’s consultant must complete an exception report. This must state the reasons why this is not possible and who will be available to give and check the intrathecal chemotherapy. The pharmacist will deliver the dose directly to the doctor (GOSH 2016) (Rationale 4).

If general anaesthesia or Entonox® is to be administered, then an anaesthetist or staff competent in the administration of Entonox® must be present ensure patient safety. The child must be starved according to hospital policy (Rationale 5).

Check intrathecal chemotherapy using procedure checklist sticker. This sticker is placed in notes post procedure. Stickers can be found in each designated area where intrathecal chemotherapy is administered with the intrathecal register.

The doctor who will administer the intrathecal medication must, together with a nurse on the intrathecal register, check patient’s treatment protocol and determine stage of treatment (Rationale 6). This must be the dated copy in the patient's medical notes. There must also be an entry in the notes stating that the patient is fit for the procedure. The doctor who will administer the intrathecal medication must also check the patient’s full blood count and that this is recorded in patient’s health care record, Minimum platelet count for the procedure needs to be 50 X 9/10 L (Rationale 7).

Clotting screen should be checked at diagnosis, a further check prior to the procedure is not necessary unless patient is unwell (e.g. septic, potential abnormal liver function tests) (Rationale 7).

Check patient’s consent form, drug chart and name band. Nurse/doctor to sign on intrathecal prescription and print names to confirm they have checked the patient's identification (Rationale 8).

Doctor to collect intrathecal chemotherapy from designated fridge and sign book and chart using full signature, to confirm that the chemotherapy has been collected from a designated area (GOSH 2016, Department of Health 2008) (Rationale 4).

Check medication according to medicine administration policy. Sign on the prescription in the medication checked section. The nurse witnessing the procedure must also sign in the relevant section. Both the doctor and the nurse must use their full signature and print their names (Department of Health 2008, GOSH 2016) (Rationale 8).

Administration via a lumbar puncture

As soon as the child is anaesthetised, they should be monitored with an oxygen saturation monitor and the following must also be observed:

Position patient on their side with head flexed onto chest and knees drawn up. (Dougherty and Lister 2011) (Rationale 12).

Put on apron and personal protective clothing ie visor and sleeves (Rationale 13).

Perform a hand wash as per hospital policy (Rationale 14, 15, 16).

  • Open sterile dressing pack and alcohol-based antiseptic ChloraPrep®, 2% chlorhexidine in 70% isopropyl alcohol or alternative (see Preparation of equipment).
  • The nurse assisting with the procedure will open intrathecal chemotherapy drugs by cutting open plastic sealed pack and place this non sterile item on a tray separately from the sterile field
  • Perform a hand wash as per hospital policy (Rationale 14, 15, 16). 
  • Put on Sterile gloves.
  •  Prepare skin and clean site using ChloraPrep®, 2% chlorhexidine in 70% isopropyl alcohol  Or alternative (see Preparation of equipment).
  •  Allow to dry (Rationale 14).

Insert a lumbar puncture needle and collect 20 drops of cerebrospinal fluid (CSF) (Rationale 17).

Connect syringe containing chemotherapy to lumbar puncture needle, and inject slowly. Repeat process for double and triple injections. No flush is required between these medicines (Rationale 18, 19).

Remove the needle and syringe when the administration is complete.

Apply pressure with gauze pad when CSF has stopped leaking. Spray with Op-site®. If CSF continues to leak, apply a small dressing with gauze and tape (Rationale 20).

This dressing must be removed within 24 hours post the procedure, or as soon as the leak has stopped (Rationale 14).

Assist the child in re-positioning if required, to promote comfort following the administration of the medication (Dougherty and Lister 2011) (Rationale 21).

Clear away equipment according to hospital waste management policy (Rationale 22).

Wash hands according to hospital policy (Rationale 15).

The doctor and the nurse must sign, using full signatures and print names, for administration of medication on the child’s prescription chart after administration is completed (Department of Health 2008, GOSH 2016) (Rationale 23, 24).

The doctor will document procedure in patient’s medical notes.

Post procedural care

If recovering from general anaesthetic or sedation, the child should continue to have their vital signs monitored and recorded until they are fully awake (Rationale 25).

The lumbar puncture site should be observed (Rationale 26) and nursing staff must be aware of side effects and complications of the procedure and of the drugs that were given.

For example:

  • infection
  • haemorrhage
  • bruising at site
  • headache
  • backache
  • arachnoiditis (inflammation of arachnoid lining caused by infection. (Killeen et al 2012, Bogod 2012). The arachnoid layer is one of the three layers of the brain and spinal cord) 
  • nausea and vomiting
  • drowsiness
  • pyrexia
  • meningitis

If any of these occur they must be recorded in the nursing notes and the doctor should also be informed (Rationale 27).

Whilst waiting for the child to regain consciousness, the noise levels in the room should be kept to a minimum (Rationale 28).

Once the child is rousable the child’s parents should be invited to return (Rationale 28).

The child should be taken back to their bed and if they wish to sleep, they can be placed in a semi prone position (Rationale 29).

If awake, the child can be nursed in any position that they are comfortable (Rationale 30).

Oxygen and suction should be available by the child’s bed (Rationale 31).

Give analgesia if required (Rationale 30).

Administration via an intraventricular access device (Ommaya reservoir)

Procedure must be performed in a designated area on a designated list (see Performing the procedure section) (GOSH 2016, Department of Health 2008) (Rationale 2).

The doctor performing the procedure must be deemed competent to access the reservoir (Rationale 19).

To be administered with local anaesthesia, such as Emla® or Ametop® (Rationale 30).

  • Check medication according to current medicine administration policy (see Performing the Procedure: general principles)
  • Position the child comfortably on parent's lap or lying down (Rationale 30).
  • Put on apron and personal protective clothing i.e. visor and sleeves (Rationale 13, 15).
  • Perform a hand wash (Rationale 15).
  • Remove Local anaesthetic cream.
  • Perform a further hand wash (Rationale 15).
  • Open sterile dressing pack and ChloraPrep®, 2% chlorhexidine in 70% isopropyl alcohol or alternative (see Preparation of equipment). 
  • The nurse assisting with the procedure will open intrareservoir chemotherapy drugs by cutting open plastic sealed pack and place this non sterile item on a tray separately from the sterile field
  • Perform a hand wash as per hospital policy (Rationale 14,15,16). 
  • Put on Sterile gloves.
  • Open an Ommaya Reservioir kit containing small non coring butterfly needle (23 or 25 gauge), devices which cannot connect to intravenous Leur connectors, (NPSA/2009/PSA004A) (Rationale 1).
  • Draw up normal saline 0.9% for injection equivalent amount to the volume of chemotherapy using syringe in Ommaya Reservoir kit which cannot connect to Leur connectors, (NPSA/2009/PSA004A) (Rationale 1).
  • Locate the reservoir by slightly depressing the dome several times.
  • Prepare skin and clean the site, using ChloraPrep®, 2% chlorhexidine in 70% isopropyl alcohol  or alternative (see Preparation of equipment). 
  • Allow to dry (Rationale 14).
  • Insert small non-coring butterfly needle (23 or 25 gauge ) device which cannot connect to intravenous Leur connectors, (NPSA/2009/PSA004A) access the reservoir and collect a small amount of CSF (Rationale 17, 32).
  • Connect syringe containing chemotherapy to butterfly needle extension and inject the medicine slowly. Disconnect the syringe.
  • Attach syringe with normal saline 0.9% for injection to the butterfly needle extension, flush with normal saline 0.9%, equivalent amount to the volume of chemotherapy given. Remove the butterfly extension needle from the reservoir.
  • Compress and release dome after all medication is given (Rationale 33, 34).
  • Remove the needle and syringe or syringe when the administration is complete.
  • Apply pressure with gauze pad. When CSF stops leaking, spray the site with Op-site spray® (Rationale 20).
  • If CSF continues to leak, apply a small dressing with gauze and tape. This dressing must be removed within 24 hours post the procedure, or as soon as the pressure dressing is no longer required (Rationale 26).
  • Assist the child in re-positioning if required, to promote comfort following the administration of the medication (Rationale 21).
  • Clear away equipment according to hospital waste policy (Rationale 22).
  • Wash hands according to hospital policy (Rationale 15).
  • The doctor and the nurse must sign for administration of medication, using full signature and print names, on the patient's prescription chart after administration is completed (Department of Health 2008, GOSH 2016) (Rationale 8).
  • The doctor will document procedure in patient’s medical notes.

Post procedural care

The nurse caring for the patient should monitor the patient for side effects of the drugs, and record these in the nursing notes. (Rationale 27) The nurse must also ensure that the parents are aware of potential side effects.

Give analgesia if required (Rationale 30).

Rationale

Rationale 1: Intrathecal chemotherapy will only be dispensed in syringes that will not connect with intravenous leur connectors. This is to ensure the correct drug is given via the correct route and prevent intravenous medications being administered intrathecally, with a potentially fatal outcome. (NPSA \2009/PSA004A).
Rationale 2: In line with updated National Guidance on the Safe Administration of Intrathecal Chemotherapy (Department of Health 2008, GOSH 2016).
Rationale 3: To allow the safe transfer of chemotherapy in line with the current policies and national guidelines (Department of Health 2008, GOSH 2016).
Rationale 4: In line with local policies and updated national guidance (Department of Health 2008, GOSH 2016)
Rationale 5: To ensure patient safety and to minimise the risk of aspiration of stomach contents whilst under anaesthetic.
Rationale 6: To ensure that medication is due according to treatment protocol.
Rationale 7: To ensure patient safety and minimise risk of bleeding.
Rationale 8: To adhere to NMC Standards for medicines management (NMC 2008) and Trust medicine administration policy.
Rationale 9: To monitor effects on cardiorespiratory systems.
Rationale 10: To determine need for suction or atropine.
Rationale 11: To determine need for suction or atropine. To determine the need for any further anaesthetic agent.
Rationale 12: To facilitate procedure.
Rationale 13: To protect staff from chemotherapy spillage in line with current policy.
Rationale 14: To. To minimise the risk of infection.
Rationale 15: To reduce the risk of cross infection and adhere to standard precautions.
Rationale 16: To prevent contamination.
Rationale 17: To send to laboratory for cytospin to look for leukaemic cells.
Rationale 18: To facilitate medication administration.
Rationale 19: To promote safe administration of medication.
Rationale 20: To prevent leakage of CSF and chemotherapy.
Rationale 21: To maintain the child's comfort.
Rationale 22: To maintain a safe environment.
Rationale 23: To maintain an accurate record of medication administered.
Rationale 24: To reduce the risk of medication being administered twice.
Rationale 25: To ensure safe recovery from sedation or anaesthesia.
Rationale 26: To ensure that there is no further leakage of CSF or chemotherapy.
Rationale 27: To ensure effective written record and to practise effectively as per the NMC Code (NMC 2015).
Rationale 28: To minimise distress.
Rationale 29: To maintain a clear airway.
Rationale 30: To facilitate comfort.
Rationale 31: To enable emergency airway support.
Rationale 32: To check free flow of CSF and patency of the reservoir.
Rationale 33: To facilitate medication administration.
Rationale 34: To disperse the drug and promote safe administration of medication.

References

D. Bogod Consultant Anaesthetist (2012) The Sting in the Tail antiseptics and the neuraxis revisited. Anaesthesia. Journal of the Association of Great Britain and Ireland. 67(12): 1305-1320. 

Department of Health (DH). (2008) HSC 2008/001 Updated national guidance on the safe administration of intrathecal chemotherapy. London, DH.

Dougherty, L. and Lister, S. (Eds). (2011) The Royal Marsden hospital Manual of Clinical Nursing Procedures 8th Edition. Sussex, John Wiley and Sons Ltd.

Great Ormond Street Hospital for Children NHS Foundation Trust. (2016) Operational policy for the prescribing, dispensing, supply and administration of intrathecal and intrareservoir cytotoxic injectons at Great Ormond Street Hospital. Version 8.1. London, Great Ormond Street Hospital

Killeen A, Kamat A, Walsh D, Parker A, Aliashkevich A. (2012) Severe adhesive arachnoiditis resulting in progressive paraplegia following obstetric spinal anaesthesia: a case report and review. Anaesthesia Journal of the Association of Great Britain and Ireland. 67(12): 1386-1394.

National Patient Safety Agency (2011) Patient Safety Alerts (NPSA/2011/PSA001 and NPSA/2009/PSA004B). Safer Spinal (Intrathecal), epidural and regional devices Part A and B.  [Last Accessed on 02.03.2017]

Nursing and Midwifery Council (NMC). (2008) Standards for the medicines management. London, NMC

Nursing and Midwifery Council (NMC). (2015) The Code, Professional standards of practice and behaviour for nurses and Midwives. London, NMC

Document control information

Lead Author(s)

Carol Walsh, Senior Staff Nurse/Specialist Nurse and Theatre Co-ordinator, Haematology/Oncology

Document owner(s)

Carol Walsh, Senior Staff Nurse/Specialist Nurse and Theatre Co-ordinator, Haematology/Oncology

Approved by

Guideline Approval Group

Reviewing and Versioning

First introduced: 
14 June 2004
Date approved: 
01 March 2017
Review schedule: 
Three years
Next review: 
01 March 2020
Document version: 
4.0
Previous version: 
3.1