Aldaquadossi 2015

Methods	Study design: parallel‐group randomised controlled trial. Setting: single centre/Egypt. Dates when study was conducted: February 2010 to July 2013.
Participants	Inclusion criteria: distal ureteric stone of < 1 cm. Exclusion criteria: bilateral ureteric stones, multiple stones, marked hydronephrosis, urinary tract infection, urinary tract anomalies, voiding dysfunction, previous open or endoscopic ureteric surgery. Diagnostic criteria: plain abdominal film, urinary tract US, and unenhanced CT of the abdomen and pelvis. Total number of participants randomly assigned: 67. Group A (Tamsulosin) Number of participants randomly assigned: 33. Age (mean): 7.7. Gender (M/F): 17/14. Group B (Ibuprofen only) Number of participants randomly assigned: 34. Age (mean): 7.25. Gender (M/F): 19/13.
Interventions	Group A (n = 33): tamsulosin 0.4 mg for patients aged > 5 years and 0.2 mg for younger children and Ibuprofen 4–10 mg/kg orally every 6–8 h as needed. Group B (n = 34): ibuprofen 4–10 mg/kg orally every 6–8 h as needed. Co‐interventions: Ketorolac 0.5–1 mg/kg intramuscularly.
Outcomes	Stone clearance How measured: spontaneous stone expulsion rate confirmed by plain film and USS. Time points measured: weekly for 4 weeks. Time points reported: not reported. Subgroup: none. Analgesic requirement How measured: patient‐reported painful episodes. Time points measured: not reported. Time points reported: not reported. Subgroup: none.
Notes	Funding Sources: none. Declaration of interests: none.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "The method of randomisation was simple random allocation of the children into the study groups." No other description of randomisation.
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote from publication: "We discussed with families the off‐label use of tamsulosin". The outcomes might be affected by lack of blinding.
Blinding of outcome assessment (detection bias) Subjective outcomes	Unclear risk	Not described.
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Not described, but objective outcomes are not likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) Stone free rate	Low risk	4 children were lost to follow‐up, 63 participants out of 67 (94.0%) were included in the evaluation.
Incomplete outcome data (attrition bias) Serious adverse events or complications of treatment	Low risk	4 children were lost to follow‐up, 63 participants out of 67 (94.0%) were included in the evaluation.
Incomplete outcome data (attrition bias) Secondary procedures	Unclear risk	No information given.
Incomplete outcome data (attrition bias) Hospital stay	Unclear risk	No information given.
Incomplete outcome data (attrition bias) Pain	Low risk	4 children were lost to follow‐up, 63 participants out of 67 (94.0%) were included in the evaluation.
Selective reporting (reporting bias)	Unclear risk	No published protocol available. No events of serious adverse event without any prespecified description.
Other bias	Low risk	Not detected.