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PAEDIATRIC HOSPITAL LEVEL ESSENTIAL MEDICINES LIST CHAPTER 11: MUSCULOSKELETAL SYSTEM NEMLC 2 MARCH 2017 GENERAL COMMENT The Paediatric Committee recommended that the Musculoskeletal System Chapter be incorporated into the Infective/Infectious Diseases Chapter. It was proposed that it be incorporated after external comment has been received. MEDICINE AMENDMENTS SECTION MEDICINE ADDED/DELETED/NOT ADDED 11.1 Arthritis, Septic (Pyogenic) Medicine Treatment Vancomycin Corticosteroids Dexamethasone Ibuprofen Therapeutic Drug Monitoring added Added Removed - Referral to Pain Chapter added 11.3 Osteitis/Osteomyelitis, Acute General and supportive measures Medicine Treatment Surgical Drainage Vancomycin Gentamicin Removed - refer to specialist for consideration of drainage Therapeutic Drug Monitoring added Therapeutic Drug Monitoring added 11.1 Arthritis, Septic (Pyogenic) Medicine Treatment Antibiotic Therapy Intravenous (IV) to oral switch outlined The Paediatric Committee recommended that IV to oral switch could occur once there was clinical improvement and the patient's inflammatory markers were normalising. The text was amended as follows: Adjust antibiotic therapy based on culture results or if response to antibiotic treatment is unsatisfactory. Where a single agent has been found to be sensitive, continue treatment on that single agent. Continue with IV antibiotics until there is evidence of good clinical response and laboratory markers of infection improve. Once clinical improvement and inflammatory markers are normalising, patients can be switched to Continue antibiotic therapy orally. Vancomycin: Therapeutic Drug Monitoring added Since long durations of antibiotic therapy is indicated for septic arthritis and osteomyelitis, the Paediatric Expert Review Committee recommended that therapeutic drug monitoring be recommended with vancomycin where available. PaedCh11_Musculoskeletal System_ 4N-March 2017 The text was amended as follows: If MRSA is suspected, replace cloxacillin with vancomycin. Vancomycin IV, 15 mg/kg/dose administered over 1 hour given 6 hourly. Where available, vancomycin doses should be adjusted on the basis of therapeutic drug levels. o Trough levels (taken immediately prior to next dose), target plasma level 15-20 mcg/mL. Level of evidence: III SAMF1, NHLS2 Corticosteroid - Dexamethasone: added Short course intravenous dexamethasone in conjunction with antibiotic therapy has been shown to lead to significant clinical and laboratory improvements, accelerated recovery and reduced long-term sequelae.3 A double-blind, placebo-controlled study evaluated 123 children with haematogenous arthritis, assigned to receive either antibiotic therapy alone or antibiotic therapy with intravenous dexamethasone (0.2 mg/kg/dose 8 hourly for 4 days). The primary outcome was a reduction of the number of patients with sequelae or dysfunction of the affected joint. After 12 months, 2% of the dexamethasone group had residual dysfunction compared to 26% in the control group. Additionally those in the dexamethasone groups had a normal C-reactive protein (CRP) and resolution of symptoms at 2.04 ± 1.25 days and 2.34 ± 5.06 respectively, compared to 4.68 ± 6.23 days and 7.81 ± 2.04 days in the control group (p=0.01 and 0.001 respectively).4 Another double-blind, placebo-controlled trial, evaluating 49 children with septic arthritis randomised to receive intravenous dexamethasone (0.15 mg/kg/dose 6 hourly for 4 days) also found a positive effect with the use of dexamethasone. The primary outcome was time to clinical and laboratory normalisation and duration of hospitalisation. Statistically significant differences were noted in the dexamethasone group for duration of fever (p=0.021), local inflammatory signs (p=0.021), levels of acute phase reactants (p=0.003) and duration of intravenous antibiotic treatment (0.007).5 The Paediatric Committee recommended that short-course corticosteroid therapy in septic arthritis should be included, and sent out for external comment. The following text was added. PLUS Corticosteroids Dexamethasone, IV, 0.15 mg/kg 6 hourly for 4 days. Pain and inflammation Ibuprofen: removed 1 South African Medicine Formulary (SAMF) 12th Edition, University of Cape Town, and Health and Medical Publishing Group. 2016 2 National Health Laboratory Services (NHLS) Reference ranges. 3 Macchiaiolo M, et al. Should steroids be used in the treatment of septic arthritis? Arch Dis Child. 2014;0:1-2. 4 Odio CM, et al. Double blind, randomized, placebo-controlled study of dexamethasone therapy for hematogenous septic arthritis in children. Pediatr Infect Dis J. 2003, 22:883-886. 5 Harel L, et al. Dexamethasone therapy for septic arthritis in children. J Pediatr Orthop. 2011; 31:211-215. PaedCh11_Musculoskeletal System_ 4N-March 2017 The Paediatric Committee outlined that ibuprofen may not be sufficient to manage the pain associated with septic arthritis, and recommended that a referral to the pain control chapter would be beneficial and outline the appropriate measures. The text was amended as follows: For pain and inflammation: Ibuprofen, oral, 5–10 mg/kg/dose, 6 hourly. Refer to Chapter 20: Pain control and palliative care 11.3 Osteitis/Osteomyelitis, Acute Surgical Drainage: Removed The Paediatric Committee was of the opinion that there appeared to be a reluctance to intervene surgically, and recommended that patients be referred for the confirmation of diagnosis and consideration of surgical drainage. The text was amended as follows: » GENERAL AND SUPPORTIVE MEASURES » Surgical drainage if: > frank pus is aspirated from bone, > clear evidence of progression to soft tissues, > when a marked improvement has not occurred within 24–36 hours on adequate IV antibiotic treatment, » coexisting septic arthritis, » Immobilise affected limb in position of function. » Supportive and symptomatic care. . . REFERRAL » Refer to specialist for confirmation of diagnosis, and consideration of surgical drainage. » Multi-organ involvement. » Failure to achieve progressive improvement on treatment. Medicine Treatment Antibiotic Therapy Intravenous (IV) to oral switch outlined The Paediatric Committee recommended that IV to oral switch could occur once there was clinical improvement and the patient's inflammatory markers were normalising. The text was amended as follows: Adjust antibiotic therapy based on culture results or if response to antibiotic treatment is unsatisfactory. Where a single agent has been found to be sensitive, continue treatment on that single agent. Continue with IV antibiotics until there is evidence of good clinical response and laboratory markers of PaedCh11_Musculoskeletal System_ 4N-March 2017 infection improve (usually about 2 weeks). Once clinical improvement and inflammatory markers are normalising, patients can be switched to oral antibiotic therapy. Oral antibiotics may then be considered. Special circumstances Vancomycin: Therapeutic Drug Monitoring added Gentamicin: Therapeutic Drug Monitoring added Since long durations of antibiotic therapy is indicated for septic arthritis and osteomyelitis, the Paediatric Expert Review Committee recommended that therapeutic drug monitoring be recommended with vancomycin and gentamicin where available. The text was amended as follows: Special Circumstances If MRSA, replace cloxacillin with vancomycin. Vancomycin IV, 15 mg/kg/dose administered over 1 hour given 6 hourly. Where available, vancomycin doses should be adjusted on the basis of therapeutic drug levels. o Trough levels (taken immediately prior to next dose), target plasma level 15-20 mcg/mL. Penetrating foot bone injuries: replace cefotaxime with ceftazidime plus aminoglycoside: Ceftazidime, IV, 50 mg/kg/dose 6 hourly. PLUS Gentamicin, IV, 6 mg/kg once daily. Where available, gentamicin doses should be adjusted on the basis of therapeutic drug levels. o Trough levels (taken immediately prior to next dose), target plasma level < 1 mg/L. o Peak levels (measured 1 hour after commencement of IV infusion or IM/IV bolus dose), target plasma level > 8 mg/L. Pain and inflammation Ibuprofen: removed The Paediatric Committee outlined that ibuprofen may not be sufficient to manage the pain associated with septic arthritis, and recommended that a referral to the pain control chapter would be beneficial and outline the appropriate measures. The text was amended as follows: For pain and inflammation: Ibuprofen, oral, 5–10 mg/kg/dose, 6 hourly. Refer to Chapter 20: Pain control and palliative care PaedCh11_Musculoskeletal System_ 4N-March 2017