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. 2018 Jun 2;2018(6):CD010784. doi: 10.1002/14651858.CD010784.pub2
Methods Study design: parallel‐group randomised controlled trial.
Setting: single centre/Turkey.
Dates when study was conducted: May 2005 to February 2008.
Participants Inclusion criteria: radiopaque lower ureteral stones 2 to 10 mm in diameter (mean +/‐ SD 6.2 +/‐ 1.1 mm).
Exclusion criteria: anatomical abnormalities, previously diagnosed reflux, voiding dysfunction, history of uretal surgery, calcium channel blockers.
Diagnostic criteria: US/XR or CT and renal function tests.
Total number of participants randomly assigned: 39.
Group A (ibuprofen and doxazosin)
  • Number of participants randomly assigned: 19.

  • Age: 6.2 +/‐ 2.4.

  • Gender (M/F): 10/3.


Group B (Ibuprofen)
  • Number of participants randomly assigned: 20.

  • Age (mean): 5.1 +/‐ 2.2.

  • Gender (M/F): 10/9.

Interventions Group A (n = 19): ibuprofen 20 mg/kg daily 2 equal doses + doxazosin 0.03 mg/kg daily at night orally, until expulsion or 3 week review.
Group B (n = 20): ibuprofen 20 mg/kg daily 2 equal doses orally, duration until expulsion or 3 week review.
Co‐interventions: none.
Outcomes Stone clearance
  • How measured: parents of all children were asked to filter the urine.

  • Time points measured: time points not reported.

  • Time points reported: not reported.

  • Subgroup: stones 0‐5 mm and stones 5‐10 mm.


Secondary procedures
  • How measured: not reported.

  • Time points measured: at 3 weeks since the start of medical management.

  • Time points reported: not reported.

  • Subgroup: none.

Notes Funding Sources: not stated.
Declaration of interests: not stated.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote from publication: 'We randomly divided patients into 2 groups'.
Process of randomisation not described.
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 and outcome data available".
Incomplete outcome data (attrition bias) Serious adverse events or complications of treatment Unclear risk No information given.
Incomplete outcome data (attrition bias) Secondary procedures Low risk Quote from publication: "All patients completed the study and outcome data available".
Incomplete outcome data (attrition bias) Hospital stay Unclear risk No information given.
Incomplete outcome data (attrition bias) Pain Unclear risk No information given.
Selective reporting (reporting bias) High risk No published protocol available. All of the outcomes were not prespecified. Study author describe that secondary procedures (SWL or ureteroscopic procedures) were applied in participants who could not pass the stone after 3 weeks, but the result was omitted.
Other bias Low risk Not detected.