| Methods |
Study design: parallel‐group randomised controlled trial. Setting: single centre/Egypt. Dates when study was conducted: April 2007 to July 2010. |
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| Participants |
Inclusion criteria: radiopaque distal ureteric calculi < 12 mm. Exclusion criteria: anatomical abnormalities, non‐radio‐opaque stones, voiding dysfunction, urinary tract infection, severe hydronephrosis, or history of endoscopic or open ureteral surgery were excluded. Diagnostic criteria: US urinary tract, KUB and renal function. NCCT in selected cases. Total number of participants randomly assigned: 61. Group A (tamsulosin)
Group B (placebo)
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|
| Interventions |
Group A (n = 33): tamsulosin 0.4 mg for children > 4 years and 0.2 mg for younger children at bedtime. Group B (n = 28): placebo. Co‐interventions: standard analgesia ibuprofen. |
|
| Outcomes |
Stone clearance
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|
| Notes |
Funding Sources: none. Declaration of interests: no conflict of interest. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from publication: "Children were randomly divided into two groups". Not specified. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Objective outcomes are not likely to be influenced by lack of blinding. |
| Incomplete outcome data (attrition bias) Stone free rate | Low risk | Quote from publication: "All patients completed the study". |
| Incomplete outcome data (attrition bias) Serious adverse events or complications of treatment | Low risk | Quote from publication: "All patients completed the study". |
| Incomplete outcome data (attrition bias) Secondary procedures | Low risk | Quote from publication: "All patients completed the study". |
| Incomplete outcome data (attrition bias) Hospital stay | Low risk | Quote from publication: "All patients completed the study". |
| Incomplete outcome data (attrition bias) Pain | Unclear risk | No information given. |
| Selective reporting (reporting bias) | Unclear risk | Secondary procedures was not specified and no published protocol available. |
| Other bias | Low risk | Not detected. |