Taddio 2008.
| Methods | Double‐blind, RCT Painful intervention: IM injections, venipunctures and heel lances Study location: Mount Sinai Hospital, Toronto, Ontario, Canada Study period: 15 September 2003 to 27 July 2004 |
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| Participants | 240 newborns, mean PMA 38.7 to 39.9 weeks, mean PNA 0.5 h to 0.8 h | |
| Interventions | 2 mL 24% sucrose given to newborns of non‐diabetic mothers (n = 60) 2 mL sterile water given to newborns of non‐diabetic mothers (n = 60) 2 mL 24% sucrose given to newborns of diabetic mothers (n = 60) 2 mL sterile water given to newborns of diabetic mothers (n = 60) Solutions were given before all IM injections, venipunctures and heel lances during the first 2 days of life |
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| Outcomes | PIPP score during procedure | |
| Notes | Student's t‐test used to compare average PIPP scores between groups. Post hoc analyses were performed after adjusting for baseline characteristics by use of a general linear model for IM injection and venipuncture and linear mixed‐model analysis for heel lances. Adverse events were analyzed using the Chi2 test or the Student t‐test Adverse effects were reported ‐ no significant differences between groups in the incidence of adverse events, which included spitting up and blood glucose levels |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random numbers table: allocation was done on a 1:1:1 basis |
| Allocation concealment (selection bias) | Low risk | Centralized at the hospital pharmacy. Solutions carried in identical bottles only labelled with patient identification |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Staff were blinded to sucrose and water solutions |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessments blinded |
| 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 |