Blass 1999.
Methods | RCT Painful intervention: heel lance Study location: Boston Medical Center, Boston, MA, USA Study period: not stated. |
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Participants | 40 term newborn infants, 34 h to 55 h old | |
Interventions | All interventions given for 2 min prior to heel lance: 2 mL 12% sucrose over 2 min via syringe (n = 10) 2 mL water via syringe over 2 min (n = 10) Pacifier dipped every 30 s in 12% sucrose solution for 2 min (n = 10) Pacifier dipped in water every 30 s for 2 min (n = 10) |
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Outcomes | Percentage of time spent crying during 3 min after heel lance, percentage of time spent grimacing, change in mean HR | |
Notes | Data were reported in graph forms only Results of ANOVA reported as P values only (we have contacted the authors to request additional information, but have received none) Adverse effects were not evaluated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | Sucrose and water alone groups blinded; pacifier + water, and pacifier + sucrose groups were blinded (although assessors could see pacifiers, they did not know which solution was being tested) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Sucrose and water alone groups blinded; pacifier + water, and pacifier + sucrose groups were blinded (although assessors could see pacifiers, they did not know which solution was being tested) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Results reported for all randomized infants |
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 |