Methods | Randomized controlled trial Duration: 18 months, from September 1991 to March 1993 |
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Participants | Number: 77 infants enrolled Inclusion criteria: regional suppurative post‐BCG adenitis Exclusion criteria: a) no sonographic sign of node collection, b) generalised adenopathy, c) immunocompromised or d) if received an anti‐tuberculous drug before referral |
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Interventions | Group 1: needle aspiration Group 2: no intervention |
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Outcomes | Clinical failure (regression of the lesion not achieved) | |
Notes | Location: Iran Setting: Not described Source of funding: Not described |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Not adequate (every other week) |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not performed, open study |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Subjective (visual inspection and measurement) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No patients were lost to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
Other bias | Unclear risk | There was insufficient information to assess whether an important risk of bias exists |