Slater 2010.
Methods | Randomized, prospective study Painful intervention: heel lance Study location: Elizabeth Garret Anderson Wing, University College Hospital, London, UK Study period: 25 February 2009 to 25 March 2010 |
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Participants | 59 infants; 29 assigned to sucrose group and 30 to water group 44 term infants 37 to 43 weeks' PMA, < 8 days old were included in the analysis of the primary outcome (pain‐specific brain activity recorded with electroencephalography and identified by principal component analysis) |
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Interventions | Sucrose group (n = 20): 0.5 mL 24% sucrose given via syringe Water group (n = 24): 0.5 mL sterile water |
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Outcomes | HR change, PIPP score, nociceptive‐specific brain activity, latency to change in facial expression(s), facial non‐responders, nociceptive reflex withdrawal activity | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomized code |
Allocation concealment (selection bias) | Low risk | Only the hospital pharmacy had access to the randomization codes that could be used to identify the solution. A sealed copy of the randomization chart was also stored in the neonatal unit in case an adverse event was reported |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants, personnel and outcome assessors blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | 59 infants were enrolled, but the primary outcome was ascertained in 44 infants (75%) |
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 |