Okan 2007.
Methods | Randomized, blinded, cross‐over trial Painful intervention: heel lance Study location: NICU, Istanbul, Turkey Study period: not stated |
|
Participants | 31 preterm infants: mean (SD) PMA 30.5 weeks (2.7); PNA 20 days (16) | |
Interventions | 2 mL sterile water
2 mL 20% sucrose
2 mL 20% glucose All solutions were given 2 min before heel lance. The infants were tested 3 times in a cross‐over manner |
|
Outcomes | HR, respiratory rate, oxygen saturation and NFCS score at baseline, heel lance and at 1, 2, 3 and 4 min post heel lance; duration of first cry and total crying time | |
Notes | The differences in duration of crying time and blood collection were analyzed using the Friedman test Results were reported as means and SDs Adverse effects were not evaluated |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Envelopes drawn randomly to determine sequence |
Allocation concealment (selection bias) | High risk | Allocated by sealed envelopes. Solutions contained in identical bottles coded by nurse who was not part of the study. Did not mention whether envelopes were opaque or sequentially numbered |
Blinding (performance bias and detection bias) All outcomes | Low risk | Sucrose and water solutions were provided blinded to staff |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “Videotape records were later analyzed by two observers who were not aware of which solution was used. Each observer assessed the data independently and could not communicate their findings to the other.” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported on 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 |