Odio 2003.

Methods	Randomised double‐blind placebo‐controlled trial
Participants	Children 3 months to 13 years of age with septic arthritis Quote: "Documented septic arthritis was considered when there were bacterial growth and purulence of the synovial fluid (purulence was defined as the presence of 5000 white blood cells/mm³, 60% of segmented forms, lactate dehydrogenase (LDH) 500 IU, glucose 30 mg/dl) or (2) bacteria isolated from blood and presence of a purulent synovial fluid with or without bacteria seen in the Gram‐stained smear" Exclusion criteria: previous history of septic arthritis in the same or the contralateral joint; arthritis secondary to a puncture wound; known history of autoimmune disease; had received steroids in the previous 2 months (except for asthma); congenital or acquired osteoarticular anomalies, history of a foreign body in the affected joint, or Gram‐negative coliform bacilli isolated from blood, cerebrospinal fluid, articular fluid, or another significant body fluid; underlying disease that would preclude the long‐term (12‐month) evaluation; had received 48 hours of treatment with an orally or parenterally administered antibiotic Total number randomised: N = 123 children (61 to the dexamethasone group and 62 to the placebo group)
Interventions	IV dexamethasone 0.2 mg/kg/dose IV every 8 hours for 12 consecutive doses. The first dose of dexamethasone was administered 15 to 20 minutes before the first dose of parenteral antibiotics All participants received antibiotic therapy; participants received 7 days of IV therapy followed by 7 or more days of ambulatory oral therapy Placebo group received 0.9% saline solution (equivalent of dexamethasone timing and volume) All participants underwent a diagnostic arthrocentesis performed by one of the orthopaedic surgeons within the first 12 hours of admission
Outcomes	1. Normal function of the affected joint at the end of therapy, at 6 months, and at 12 months ‐ reported as dichotomous result 2. Secondary endpoint: speed of clinical and laboratory normalisation (days to resolution of symptoms, including absence of fever, absence of spontaneous pain or pain to passive or active movement, absence of warmth and oedema, normal range of movement of the joint, and days of normalisation of serum C‐reactive protein) 3. Duration of intravenous/oral administration of antibiotics, duration of intravenous/oral administration of antibiotics
Comparison	Placebo
Notes	Parents or legal guardians providing written informed consent were eligible for the study No funding support
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "After enrolment patients were selected from a list of computer‐generated random numbers kept by the Pharmacist (GA) to receive in a 1:1 randomisation: dexamethasone 0.2 mg/kg/dose iv every 8 h for 12 consecutive doses; or saline at an equivalent volume of that of the corresponding dexamethasone, given iv at the same intervals and number of doses"
Allocation concealment (selection bias)	Low risk	Quote: "Treatment was allocated by opening of sequential, blinded envelopes containing drug assignments"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Received saline at an equivalent volume of that of the corresponding dexamethasone, given iv at the same intervals and number of doses. Blinded envelopes containing drug assignments"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not mentioned
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "Overall 123 children who were asked to participate were enrolled in the study" 61 dexamethasone; 62 placebo 23 children were unavailable for various reasons 100 participants were fully evaluated (50 intervention group; 50 control group)
Selective reporting (reporting bias)	Unclear risk	Study authors did not report clearly their prespecified outcome "range of movement of the joint"
Other bias	Low risk	Not detected

CRP: C‐reactive protein.

ESR: erythrocyte sedimentation rate.

LDH: lactate dehydrogenase.

WBC: white blood cell.