Tutag Lehr 2015.
| Methods | RCT Painful intervention: heel lance Study location: Hutzel Harper University Hospital, Detroit, MI, USA Study period 2005 to 2007 |
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| Participants | 56 term infants ≤ 7 days old: appropriate for PMA (weight between 5th to 95th percentile) scheduled to undergo routine heel lance for newborn metabolic screening | |
| Interventions | Sucrose group (n = 29): infants received 2.0 mL 24% sucrose orally Water group (n = 27): infants received sterile water orally Feedings were withheld 2.0 h prior to heel lance to minimize risk of aspiration. No infant received NNS (pacifiers) during the study |
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| Outcomes | Primary outcomes: mean skin blood flow; NIPS Skin blood flow, perfusion units measured by Laser Doppler Imager during heel lance HR, RR, oxygen saturation in blood |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A computer‐generated block method |
| Allocation concealment (selection bias) | Low risk | Pharmacy Investigational Drug Service team at Hutzel Harper University Hospital maintained the double‐blinded randomization sequence |
| Blinding (performance bias and detection bias) All outcomes | Low risk | A computer‐generated block method assigned infants to receive either 2 mL 24% sucrose or 2 mL sterile water placebo prior to heel lance |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Doses were dispensed in plastic oral syringes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | In the sucrose group (n = 30) 1 infant was excluded secondary to withdrawn consent. In the placebo group (n = 30) 3 infants were not included: 1 had a significant Laser Doppler Imager scan artefact, 1 received oral acetaminophen prior to heel lance, and 1 developed persistent tachypnoea prior to the study |
| Selective reporting (reporting bias) | Unclear risk | We could not determine whether this study was registered in a trials registry, so we could not tell if there were any deviations from the protocol |
| Other bias | Low risk | Appears free of other bias. |