Gaspardo 2008.
Methods | Randomized, double‐blind, controlled trial Painful intervention: venipuncture, arterial puncture, heel lance, intravenous cannulation, endotracheal tube introduction, endotracheal tube suctioning, gavage insertion for feeding, removal of electrode leads and tape Study location: NICU of the Hospital of Clinics, School of Medicine, University of São Paulo at Ribeirão Preto, Preto, Brasil Study period: April 2003 and September 2005 |
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Participants | 33 preterm infants, median PMA 30 weeks | |
Interventions | On day 1, no treatment was given to any neonate in order to collect baseline data. On days 2 to 4 solutions (sucrose or water) were administered to neonates before every painful procedure (listed above): 0.5 mL/kg 25% sucrose before every minor painful procedure listed above (n = 17) 0.5 mL/kg sterile water before every minor painful procedure listed above (n = 16) |
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Outcomes | Incidence of cry (percentage of neonates crying), HR (percentage of neonates with HR ≥ 160 beats/min), NFCS (percentage of neonates with score ≥ 3), Activated Behavioural State (percentage of neonates with score ≥ 4) | |
Notes | Pain was assessed over 4 days during morning blood collection (heel lance) The Mann‐Whitney U test was used to calculate the difference between sucrose and water groups for continuous variables. The Chi2 test was used to calculate the difference between sucrose and water groups for categorical variables No means or standard deviations were reported. NFCS results were reported in graph form only Adverse events were assessed |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization sequence |
Allocation concealment (selection bias) | Low risk | Solutions prepared by pharmacist labelled 'A' or 'B' to keep identity from investigators. Co‐ordinator kept identities of solutions in sealed and opaque envelopes until after analysis |
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 | Blinding of outcome assessments |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 11/ 44 enrolled infants were discharged from the NICU while the data collection was in progress and 33 infants completed the study |
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 |