Guidelines Document Title: Document ID: Document Name: Surgical antibiotic prophylaxis paediatric patients GD-CLN-700003 GD-CLN-700003 Version Number: 1.2 Revision Date: 30/08/2016 Key Words Antimicrobial stewardship, antibiotics, antibiotic, surgical, surgery, prophylaxis, medication, paediatric, children Internal Use Only: The Material within this document has been developed solely for the internal business purposes of Mater Health Services. Disclosure of information of this classification may result in a breach of statutory or regulatory obligations by the Mater. NOTICE OF CURRENCY: If viewing a printed copy of this document, NEVER assume that the printed copy being viewed is current. Always check the online Mater Document Centre to confirm you are viewing the current version of this guideline. Our Mission Our Vision Our Values In the spirit of the Sisters of Mercy, Mater Health Services offer compassionate service to the sick and needy, promotes an holistic approach to healthcare in response to changing community needs and foster high standards in health-related education and research. Following the example of Christ the healer, we commit ourselves to offering these services without discrimination. In the Mercy tradition, Mater will be renowned as a leader in the delivery of exceptional healthcare and experienced by all as a community of compassion. Mercy Dignity Care Commitment Quality Affirmation This governance document is consistent with the Mater Values and supports the Mater s Mission and Vision by establishing and mandating appropriate controls to support the delivery of health care services. Copyright Mater Misericordiae Health Services Brisbane Limited. All Rights Reserved.
Table of Contents 1 Document Controls... 3 1.1 Document Revision History... 3 1.2 Document Review and Approval... 3 1.3 References... 3 2 Introduction... 4 2.1 Purpose... 4 2.2 Scope and Context... 4 3 Guidelines... 4 3.1 General Information... 4 4 Appendices... 5 4.1 Appendix 1: MHS Recommendations for paediatric surgical antibiotic prophylaxis... 5 Head and neck surgery.5 Thoracic surgery 6 Abdominal surgery..6 Neurosurgery..7 Cardiac surgery..7 Orthopaedic surgery..8 Amputation lower limb 9 Urological surgery. 10 Copyright Mater Misericordiae Health Services Brisbane Limited. All Rights Reserved.
1 Document Controls 1.1 Document Revision History Version Date Description 1 30-Jun-2016 Version 1 for published on the Mater Document Centre 1.1 01-Aug-2016 Amendment requested by Nicola Townell (AMS Physician) and approved by Catherine Gilbert: Statement added to MHS recommendations for paediatric surgical antibiotic prophylaxis (top of page 5) about timing of antibiotic administration refer to fifth dot point. 1.2 30-Aug-2016 Amendment requested by Anna Klusak (AMS Pharmacist): Tallman lettering added throughout the document. 1.2 Document Review and Approval Person Name / Committee Position (if applicable) Function (Owner Approve Review) Anna Klusak Antimicrobial Stewardship Pharmacist Document author Nicola Townell Infectious Diseases/AMS physician Document author Steve Parry-Jones Director of Pharmacy Document owner Antimicrobial Stewardship Working Party Clinical Policy Governance Committee Review/approve Endorse 1.3 References Internal Documents Document Type Document ID Document Title Governing PY-CLN-900018 Prescribing, administration and safe management of medications Supporting PR-CLN-900060 Antimicrobial prescribing and management Related PY-AWC-000536 Administration and safe management of medication paediatric patients GD-CLN-700001 Paediatric patients parenteral aminoglycoside dosing and monitoring guidelines PR-CLN-000016 Medication abbreviation plus Tallman External Documents 1 : surgical [revised 2016 Mar] In: etg complete [Internet]. Melbourne: Therapeutic Guidelines Limited; 2014 Nov 2 Duguid M, Cruickshank M (eds). Antimicrobial Stewardship in Australian Hospitals. Australian Commission on Safety and Quality in Healthcare. 2011 [online] [accessed 02/06/2014] http://www.health.gov.au/internet/safety/publishing.nsf/content/ba31d58417a40e8cca2578620002ee1b/ $File/AMS-PRELIMS-EXEC%20SUMMARY.PDF 3 Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013,70(1):195-283. Document Title: Guidelines for Surgical antibiotic prophylaxis paediatric patients Page 3 of 12
4 Steinberg JP, Braun BI, Hellinger WC, Kusek L, Bozikis MR, Bush AJ, et al. Timing of antimicrobial prophylaxis and the risk of surgical site infections: Results from the trial to reduce antimicrobial prophylaxis errors. Ann Surg 2009;250(1):10-6. 2 Introduction 2.1 Purpose This guideline is to provide a standardised approach to the appropriate use and prescribing of surgical antibiotic prophylaxis to minimise surgical site infections. The objective of this guideline is to minimise the selection of antibiotic-resistant organisms and promote safe and effective antibiotic prescribing. Inappropriate prescribing is wasteful and may endanger patient wellbeing. The primary basis for decision-making approval is the latest edition of the Therapeutic Guidelines. 1 2.2 Scope and Context This guideline applies to all staff working within Mater Health (MH) relating to paediatric patients who require surgical antibiotic prophylaxis. 3 Guidelines 3.1 General Information a. The process for administration of antibiotic prophylaxis should be standardised to ensure consistent, timely administration. There is evidence to suggest that optimal timing of antibiotic prophylaxis prior to surgery is within the period 15-30 minutes. Thus it is recommended that antibiotics be administered within this window. Antibiotics requiring longer infusion times should be administered such that the infusion is complete during this time. b. The guidelines for surgical antibiotic prophylaxis and the administration process should be reviewed regularly and in accordance with the published Therapeutic Guidelines. 1 c. The choice of antibiotic should be in accordance with the published Therapeutic Guidelines and be guided by previous microbiological results and known colonisations. For further advice please contact Infectious Diseases. d. Implementation of these recommendations will mean that the health service has taken responsible steps to respond to the legal duty to improve the quality of care provided with regard to the surgical antibiotic prophylaxis standard. e. The current MH recommendations are available in all operating theatres and via the Intranet. f. Compliance with surgical antibiotic prophylaxis will be monitored via the Infection Control surgical site surveillance program and results reported to the Infection Control Committees and the Health Quality and Complaints Commission (HQCC). g. Antibiotic dose and timing must be clearly and accurately documented on the anaesthetic record. Document Title: Guidelines for Surgical antibiotic prophylaxis paediatric patients Page 4 of 12
4 Appendices 4.1 Appendix 1: MHS Recommendations for paediatric surgical antibiotic prophylaxis FOX MHS recommendations for paediatric surgical antibiotic prophylaxis If patient is known or suspected to be colonised with a resistant organism OR has a history of overseas travel (India, Asia, Southern Europe) in the last 12 months, or known contraindications to agents listed below, contact ID/Clinical Microbiology for advice Post-operative antibiotics are NOT indicated unless infection is confirmed or suspected, regardless of the presence of surgical drains or indwelling urinary catheters If infection is suspected, consider modification of antibiotic regimen according to clinical condition and microbiology results One dose of antibiotic is generally sufficient. Second dose is indicated if surgery delayed or prolonged beyond antibiotic re-dosing times- see Table A below. Antibiotics should be administered within an hour of surgical (ideally within 15-30 minutes ) Surgical indication a) Incision through oral, nasal, pharyngeal or oesophageal mucosa; stapedectomy or similar operations b) Procedures that involve insertion of prosthetic material Exclusions: tonsillectomy, adenoidectomy, thyroidectomy, nasal septoplasty, endoscopic sinus surgery or uncontaminated neck dissection Table A: Recommended antibiotic re- dosing times 8 Antibiotic Re-dosing interval cefazolin 4 hours cefoxitin 2 hours clindamycin 4 hours gentamicin NA metronidazole 12 hours vancomycin* 8 hours Head and neck surgery cefazolin 30 mg/kg up to 2g within the period 15-30 minutes prior to first PLUS (for through mucosal surfaces) metronidazole 12.5 mg/kg up to 500 mg IV 15-30 minutes Table B: Recommended rates for IV infusions Antibiotic Rate clindamycin 30 mg/minute. Dilute to 18 mg/ml or weaker prior to infusion. metronidazole 25 mg/minute vancomycin* 15 mg/minute (~1 g/hr) 15-30 minutes before first methicillin-resistant Staphylococcus aureus (MRSA) Document Title: Guidelines for Surgical antibiotic prophylaxis paediatric patients Page 5 of 12
a) Thoracic surgery including VATS procedure Thoracic surgery cefazolin 30 mg/kg up to 2g within the period 15-30 minutes prior to first Abdominal Surgery 15-30 minutes before first Document Title: Guidelines for Surgical antibiotic prophylaxis paediatric patients Page 6 of 12 methicillin-resistant Staphylococcus aureus (MRSA) 30 minutes before first Patients with specific cardiac conditions undergoing gastrointestinal tract procedures where antibiotic prophylaxis is routinely indicated require antibiotics for the prevention of infective endocarditis. See end of table ## a) Gastroduodenal /oesophageal procedures entering GIT lumen or for procedures NOT entering the lumen, only for patients with risk factors for postoperative infection e.g. obesity; immunocompromise; gastric outlet obstruction; reduced gastric acidity or motility; gastrointestinal bleeding, malignancy or perforation b) Biliary procedures for patients with risk factors or surgical risk factors for postoperative infection e.g. diabetes, obstructive jaundice, common bile duct stones, acute cholecystitis or nonfunctioning gall bladder; and open cholecystectomy Exclusions: Low risk, uncomplicated elective biliary procedures, including laparoscopic surgery c) Small intestine Exclusions: endoscopic procedures d) Colorectal surgery and appendicectomy cefoxitin 40 mg/kg up to 2 g IV 15-30 minutes before first PLUS gentamicin 5 mg/kg ideal body weight^ IV 30 minutes before first
a) Craniotomy when procedure is prolonged, re-explorations and microsurgery, insertion of prosthetic material Ventricular drains that remain in situ are not a justification to extend the duration of antibiotic prophylaxis beyond what is otherwise indicated for a specific procedure. Neurosurgery cefazolin 30 mg/kg up to 2g completed within the period 15-30 minutes Cardiac Surgery Infusion to be completed within the methicillin-resistant Staphylococcus aureus (MRSA) Infusion to be started at least 1 hour prior and ideally completed within the For ESBL colonisation or infection: contact infectious diseases for advice For eradication of Staphylococcus aureus nasal colonisation use Mupirocin 2% (bactroban) nasal ointment intransally for 2 days prior to surgery (if possible) for a total of 5 days a) valve replacement, coronary artery bypass surgery, cardiac transplantation, transcatheter aortic valve implantation (TAVI) and insertion of ventricular assist devices b) Device insertions Insertion of implantable cardiac devices such as permanent pacemakers, cardioverterdefibrilators or cardiac resynchronisation devices cefazolin 50 mg/kg up to 2 g IV then 8-hourly for up to 2 further doses cefazolin 50 mg/kg up to 2 g IV 15-30 minutes before first then 8-hourly for up to 2 further doses PLUS gentamicin 5 mg/kg ideal body weight^ IV 15-30 minutes before first PLUS gentamicin 5 mg/kg ideal body weight^ IV 30 minutes before first Consider repeating the dose after 12 hours 30 minutes before first Document Title: Guidelines for Surgical antibiotic prophylaxis paediatric patients Page 7 of 12
a) Procedures involving insertion of prosthetic or transplant material; internal fixation of fractures, spinal surgery and arthroscopic procedures involving insertion of prosthetic material, avascular tissue, or patient is immunocompromised. Exclusions: routine arthroscopic procedures a) Open fractures Orthopaedic surgery cefazolin 30 mg/kg up to 2g completed within the period 15-30 minutes. cefazolin 50 mg/kg up to 2g completed within the period 15-30 minutes. Infusion to be completed within the clindamycin 15mg/kg up to 600mg Infusion to be completed within the methicillin-resistant Staphylococcus aureus (MRSA) Infusion to be started at least 1 hour prior and ideally completed within the Continue dosing 8 hourly for 24-72 hours if debridement has occurred within 8 hours of injury. If more than 8 hours after injury, give presumptive treatment for 7 days, even if there is no evidence of infection Continue dosing 8 hourly for 24-72 hours if debridement has occurred within 8 hours of injury. If more than 8 hours after injury, give presumptive treatment for 7 days, even if there is no evidence of infection. Switch to oral therapy when patient able to tolerate (10mg/kg up to 450mg 8 hourly) Document Title: Guidelines for Surgical antibiotic prophylaxis paediatric patients Page 8 of 12
Amputation Lower Limb methicillin-resistant Staphylococcus aureus (MRSA) Exclusions: receiving treatment for established infection. Dose and timing should be adjusted to ensure adequate tissue concentrations at time of. In these patients, antibiotic treatment can be stopped 2-5 days after amputation if infected bone and tissue removed cefazolin 30 mg/kg up to 2 g IV within the period 15-30 minutes prior to first, then 8 hourly for up to 2 further doses IF limb is ischaemic ADD metronidazole 12.5 mg/kg up to 500 mg IV to be completed within the period 15-30 minutes Consider repeating dose after 12 hours Consider repeating dose of vancomycin 15mg/kg after 12 hours Infusion to be started at least 1 hour prior and ideally completed within the PLUS gentamicin 5mg/kg ideal body weight^ IV ADD (where required): Consider repeating dose of vancomycin 15mg/kg after 12 hours Infusion to be started at least 1 hour prior and ideally completed within the IF limb is ischaemic ADD metronidazole 12.5 mg/kg up to 500 mg IV To be completed within the period 15-30 minutes Consider repeating dose after 12 hours Document Title: Guidelines for Surgical antibiotic prophylaxis paediatric patients Page 9 of 12
Urological surgery methicillin-resistant Staphylococcus aureus (MRSA) Preoperative urine cultures are recommended before elective urological procedures. Treatment is recommended for patients with significant bacteriuria even if they are asymptomatic due to increased risk of postoperative infection. Treat with a short course of antibiotics, as per recommendations for acute cystitis in adults and children in the Therapeutic Guidelines: Antibiotic 1 and guided by the results of cultures and susceptibility testing Patients with specific cardiac conditions undergoing genitourinary tract procedures require antibiotics for the prevention of infective endocarditis. See end of table ## a) Endoscopic procedures Intrarenal and ureteric stone procedures (e.g. percutaneous nephrolithotomy, ureteroscopy or pyeloscopy for ureteric or renal stones) Specific risk for infection (e.g. resection of large or necrotic tumors, risk of bleeding, bladder outlet obstruction with incomplete bladder emptying) b) Open or laparoscopic urological procedures where the urinary tract is NOT entered* is NOT required for patients with sterile urine unless the patient has risk factors for post-operative infection or the procedure involves implantation of prosthetic devices. Consider prophylaxis where immediate operation is required and bacteriuria cannot be excluded. cefazolin 30 mg/kg up to 2 g IV cefazolin 30 mg/kg up to 2g For implantation of prosthetic material gentamicin 2 mg/kg ideal body weight^ IV If gentamicin is contraindicated or relevant precautions preclude its use, REPLACE gentamicin with: trimethoprim + sulfamethoxazole child 1 month or older: 4 + 20 mg/kg up to 160 + 800 mg orally 60 minutes before the procedure gentamicin 2 mg/kg IV ideal body weight^ REPLACE cefazolin with: 30 minutes before first 30 minutes before first ADD (where required): 30 minutes before first Document Title: Guidelines for Surgical antibiotic prophylaxis paediatric patients Page 10 of 12
Urological surgery methicillin-resistant Staphylococcus aureus (MRSA) Preoperative urine cultures are recommended before elective urological procedures. Treatment is recommended for patients with significant bacteriuria even if they are asymptomatic due to increased risk of postoperative infection. Treat with a short course of antibiotics, as per recommendations for acute cystitis in adults and children in the Therapeutic Guidelines: Antibiotic 1 and guided by the results of cultures and susceptibility testing Patients with specific cardiac conditions undergoing genitourinary tract procedures require antibiotics for the prevention of infective endocarditis. See end of table ## c) Open or laparoscopic urological procedures where the urinary tract IS entered* cefazolin 30 mg/kg up to 2g IV For implantation of prosthetic material gentamicin 2 mg/kg ideal body weight^ IV If gentamicin is contraindicated or relevant precautions preclude its use, REPLACE gentamicin with: 30 minutes before first PLUS gentamicin 2 mg/kg ideal body weight^ IV ADD (where required): 30 minutes before first trimethoprim + sulfamethoxazole child 1 month or older: 4 + 20mg/kg up to 160 + 800 mg orally 60 minutes before the procedure IF there is a risk of entry in to the bowel lumen metronidazole 12.5 mg/kg up to 500 mg IV 15-30 minutes If gentamicin is contraindicated or relevant precautions preclude its use, REPLACE gentamicin with: trimethoprim + sulfamethoxazole child 1 month or older: 4+20 mg/kg up to 160 + 800 mg orally 60 minutes before the procedure IF there is a risk of entry in to the bowel lumen metronidazole 12.5 mg/kg up to 500 mg IV 15-30 minutes Document Title: Guidelines for Surgical antibiotic prophylaxis paediatric patients Page 11 of 12
Urological surgery Document Title: Guidelines for Surgical antibiotic prophylaxis paediatric patients Page 12 of 12 methicillin-resistant Staphylococcus aureus (MRSA) Preoperative urine cultures are recommended before elective urological procedures. Treatment is recommended for patients with significant bacteriuria even if they are asymptomatic due to increased risk of postoperative infection. Treat with a short course of antibiotics, as per recommendations for acute cystitis in adults and children in the Therapeutic Guidelines: Antibiotic 1 and guided by the results of cultures and susceptibility testing Patients with specific cardiac conditions undergoing genitourinary tract procedures require antibiotics for the prevention of infective endocarditis. See end of table ## a) Extracorporeal Shock Wave Lithotripsy (ESWL)* only required if unknown or high risk of infection ( e.g. previous infection even if urine currently sterile or if the procedure is required immediately and bacteriuria cannot be excluded) cefazolin 30 mg/kg up to 2g IV gentamicin 2 mg/kg IV ideal body weight^ a) Other clean procedures generally NOT recommended ^Calculate ideal body weight in children based on matching height percentile. Use World Health Organization (WHO) growth charts for 0 2 years found at: http://www.cdc.gov/growthcharts/who_charts.htm#the WHO Growth Charts and The Center for Disease Control s (CDC) growth charts for 2 18 years found at: http://www.cdc.gov/growthcharts/ *vancomycin Maximum dose 2g Rate of 15mg/min recommended to minimise the risk of red man syndrome. Rate may be increased as tolerated Vancomycin infusion to be started at least one hour before surgery and can be continued into the operative period if necessary provided more than 75% of the dose has been administered prior to Vancomycin is the preferred glycopeptide, with greater evidence to support its use in surgical prophylaxis. Tecioplanin can be used as an alternative to vancomycin in the true emergency setting, allergic reaction or if vancomycin infusion cannot be commenced an hour prior to time. Use 10mg/kg actual body weight up to 800mg maximum dose ##Antibiotic prophylaxis for endocarditis is recommended in patients with the following cardiac conditions: prosthetic cardiac valve or prosthetic material used for cardiac valve repair previous infective endocarditis congenital heart disease but only if it involves: o unrepaired cyanotic defects, including palliative shunts and conduits o completely repaired defects with prosthetic material or devices, whether placed by surgery or catheter intervention, during the first 6 months after the procedure (after which the prosthetic material is likely to have been endothelialised) o repaired defects with residual defects at or adjacent to the site of a prosthetic patch or device (which inhibit endothelialisation) rheumatic heart disease in high-risk patients (Indigenous Australians and those who are at significant socioeconomic disadvantage) AND undergoing the following procedures: Abdominal surgery and gastrointestinal endoscopic procedures : all procedures listed above except for gastrostomy or jejunostomy tube insertion Urological surgery: All procedures involving manipulation of the urinary tract Head and neck surgery: tonsillectomy or adenoidectomy Use the following antibiotics: Where the listed regimens above do not contain vancomycin, use: amoxy/ampicillin 50 mg/kg up to 2 g IV, completed within 15 to 30 minutes prior to skin If patient is allergic to penicillin, use vancomycin* 30mg/kg (for children younger than 12 years) or 25mg/kg (for children older than 12 years) up to 2g