Yilmaz 2011.
| Methods | Randomised controlled trial I. Masking of randomisation ‐ unclear II. Masking of intervention ‐ unclear III. Masking of outcome assessment ‐ unclear IV. Completeness of follow‐up ‐ low risk | |
| Participants | 120 term infants undergoing heel lance blood sampling for screening tests
Exclusion criteria: preterm neonates, neonates with Apgar score < 7 at 1 and 5 minutes, neonates with low birth weight (< 2500 g), sick neonates, newborns with congenital anomalies and newborns born by vaginal delivery
Group 1: 30 neonates
Mean (SD) GA ‐ 39.1 (+/‐ 1.03) weeks
Mean (SD) BW ‐ 3363 (+/‐ 391) grams
Group 2: 30 neonates
Mean (SD) GA ‐ 39.1 (+/‐0.71) weeks
Mean (SD) BW ‐ 3400 (+/‐ 353) grams
Group 3: 30 neonates
Mean (SD) GA ‐ 39.2 (+/‐ 0.93) weeks
Mean (SD) BW ‐ 3298 (+/‐ 406) grams Group 4: 30 neonates Mean (SD) GA‐ 39.7 (+/‐ 0.8) weeks Mean (SD) BW ‐ 3391 (+/‐ 383) grams |
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| Interventions | All infants were fed half an hour before the procedure
Group 1: 2 ml of breast milk
Group 2: 2 ml of 20% sucrose
Group 3: non‐nutritive sucking (pacifier) Group 4: control (no intervention) The solutions were administered by syringe avoiding contact of the syringe with the mouth and lips Heel lance was performed 2 minutes after administration of the solution |
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| Outcomes | NIPS Change in heart rate, saturation of oxygen, respiratory rate and body temperature |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information in terms of the randomisation and allocation concealment |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | No information is given regarding blinding. We do not have information either on whether the investigators analysing the video tapes for the NIPS were blinded to the infants' intervention |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Authors mention saturation of oxygen as one of the outcomes, and they say there was no significant difference amongst the groups, but they do not show the data |
| Selective reporting (reporting bias) | High risk | There is no data for one of the prespecified outcomes, oxygen saturation |
| Other bias | Unclear risk | Protocol not available to compare |
BW: birth weight DAN: Douleur Aigue Nouveau‐ne GA: gestational age NFCS: Neonatal Facial Coding Score NIPS: Neonatal Infant Pain Score NNS: non‐nutritive sucking PIPP: Premature Infant Pain Profile SD: standard deviation
EBM: expressed breast milk CPAP: continuous positive airway pressure