Acharya 2004.
Methods | Double‐blind, randomized, controlled, cross‐over trial Painful intervention: venipuncture Study location: NICU at Leicester Royal Infirmary, UK Study period: not stated. |
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Participants | 39 healthy preterm neonates (mean 30.5 (SD 2.3) weeks' GA), mean PNA 27.2 (SD 24.4) days | |
Interventions | 2 mL 25% (0.5 g) sucrose (n = 39) via syringe over 2 min into infant's mouth before 2 routine venipunctures 2 mL water (n = 39) via syringe over 2 min into infant's mouth before 2 routine venipunctures | |
Outcomes | Rise in HR, oxygen saturation, duration of first cry, total duration of crying, NFCS at the 3 phases of the venipuncture | |
Notes | Data were reported using means, SDs over the 3 phases of the venipuncture. Data could not be abstracted for the 2 groups prior to cross‐over. Adverse effects were evaluated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Selected from random number table by a hospital pharmacist |
Allocation concealment (selection bias) | Low risk | Allocation controlled by a hospital pharmacist |
Blinding (performance bias and detection bias) All outcomes | Low risk | Interventions blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessments were done blinded to intervention group |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Inconsistent number of infants reported in Methods section (n = 39) versus discussion section (n = 28) |
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 |