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. 2018 Nov 21;2018(11):CD012125. doi: 10.1002/14651858.CD012125.pub2

Harel 2011.

Methods Randomised double‐blind placebo‐controlled trial
Participants Children aged 6 months to 18 years with septic arthritis hospitalised at Schneider Children’s Medical Center of Israel, and at Sapir Medical Center, from March 1999 to December 2007
Diagnosis: "the diagnosis of septic arthritis was based on 3 criteria: (1) acute onset of swelling, pain, local warmth, and severe limitation of motion in any joint,except for the hip or shoulder, in which severe pain and limitation of motion were sufficient for diagnosis; (2) all involved joints were aspirated on admission. Joint fluid with a turbid purulent appearance and containing 50,000 white blood cells (WBC)/mm³ was considered septic; (3) elevated levels of acute phase reactants:erythrocyte sedimentation rate (ESR), C‐reactive protein (CRP), or WBC count. In all patients both synovial fluid and blood were cultured before treatment"
Exclusion criteria: history of chronic arthritis, autoimmune disease, or immune deficiency; arthritis secondary to a puncture wound
Total number randomised: N = 49 (24 assigned to the dexamethasone group and 25 to the placebo group)
Interventions Dexamethasone IV 0.15 mg/kg/dose every 6 hours for 16 consecutive doses (4 days); administered 30 minutes before and up to 2 hours after the first dose of parenteral antibiotics
Placebo group received 0.9% saline solution (equivalent to dexamethasone timing and volume)
All participants received antibiotic therapy, first parenteral and then oral. Some participants underwent surgical drainage. No participants received anti‐inflammatory drugs
Outcomes
  1. Pain reported as dichotomous scale (presence/absence) at long‐term follow‐up (12 months); assessed by phone call

  2. Serious adverse events reported at long term as dichotomous scale

  3. Outcome not reported; length of hospital stay reported as proxy number of days of IV antibiotic treatment; outcome reported as a narrative statement

  4. Duration of intravenous/oral administration of antibiotics

  5. Secondary endpoint: presence of late sequelae (follow‐up at 2, 5, 12 months)

  6. Time to clinical and laboratory normalisation and duration of hospitalisation (first day fever ‐ first day no local heat ‐ first day no redness ‐ first day pain free ‐ first day full range of movement ‐ first day normal function ‐ last day ESR +25 mm/h ‐ last day WBC +15.000 ‐ last day CRP +0.5 mg/dL)

  7. Each parameter rated on a scale of 1 (least severe) to 3 (most severe). Scores summed to determine the arthritis index

Comparison Placebo
Notes No funding support
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "After enrolment, patients were allocated 1:1 to receive dexamethasone or placebo according to a list of computer‐generated random numbers kept by the pharmacist"
Allocation concealment (selection bias) Low risk Randomisation was performed in the pharmacy, and researchers seemed not to be aware of which participants would receive treatment or placebo
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: The bottles were labelled "dexamethasone study"
Placebo consisted of saline only, packaged in identical bottles
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Researchers did not know which group participants belonged to at the time of evaluation of the affected joint
Incomplete outcome data (attrition bias) 
 All outcomes High risk "The study protocol was offered to the parents of 60 children, of whom 11 refused to participate"
49 children were randomised to intervention (24) and control groups (25). No participants were lost in the short‐term follow‐up period, but in the long‐term follow‐up period, 4/49 were lost at 2 months, 10/49 at 6 months, and 20/49 at 12 months
Selective reporting (reporting bias) High risk This study did not report its primary outcome details (length of hospital stay). In addition, study authors did not provide clear information on long‐term results or measurement of sequelae
Other bias Low risk