Rogers 2006.
Methods | Randomized, double‐blind trial Painful intervention: bladder catheterization Study location: a single tertiary‐care dedicated paediatric emergency department, USA Study period: June 2003 to November 2004 |
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Participants | 83 infants ≤ 90 days old, born at least 34 weeks' PMA were enrolled and randomized, 3 infants were withdrawn after randomization Separated into 3 age groups:
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Interventions | 2 mL 24% sucrose via syringe 2 min before bladder catheterization (n = 40) 2 mL sterile water via syringe 2 min before bladder catheterization (n = 40) |
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Outcomes | DAN scale, percentage cry, time to return to behavioural baseline | |
Notes | Post hoc subgroup analyses, t‐tests, Chi2 tests, Mann‐Whitney test, ANOVA and Breslow‐Day (BD) test for homogeneity used to evaluate outcomes Results were reported as means and SDs. P values were reported Adverse events were evaluated; no adverse effects experienced |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence generated by random number table |
Allocation concealment (selection bias) | Low risk | Syringes were coded by pharmacy and solutions were indistinguishable |
Blinding (performance bias and detection bias) All outcomes | Low risk | Staff blinded to sucrose and water solutions |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Research nurses were blinded to the treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 83 infants were enrolled and randomized, but 3 were withdrawn after randomizations as a result of inappropriate enrolment or withdrawal of consent |
Selective reporting (reporting bias) | Unclear risk | The study protocol was not available to us so we could not judge whether there were any deviations from it |
Other bias | Low risk | Appears free of other bias |