| Methods |
Randomised controlled trial
I. Masking of randomisation ‐ low risk
II. Masking of intervention ‐ low risk
III. Masking of outcome assessment ‐ low risk
IV. Completeness of follow‐up ‐ low risk |
| Participants |
80 stable full‐term newborn infants undergoing routine newborn screening (heel lance) on postnatal day 3 were randomly assigned to one of the 4 treatment groups
Group 1: 20 neonates
Mean (range) BW ‐ 3420 (2650 to 5000) grams
Male: Female ‐ 10: 10
Group 2: 20 neonates
Mean (range) BW ‐ 3430 (2640 to 3960) grams
Male: Female ‐ 10:10
Group 3: 20 neonates
Mean (range) BW ‐ 3350 (2720 to 4200) grams
Male: Female ‐ 8:12
Group 4: 20 neonates
Mean (range) BW ‐ 3410 (2740 to 4170) grams
Male: Female ‐ 9:11 |
| Interventions |
Group 1: 2 ml of artificial sweetener
Group 2: 2 ml of glycine
Group 3: 2 ml of breast milk
Group 4: 2 ml of sterile water |
| Outcomes |
Heart rate change
Percentage time crying
Body pain score
Facial pain score
Combined pain score |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
Adequate. Randomisation was done through sealed envelopes |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
A nurse administered the solution in the absence of investigators and was not involved in heel prick or data collection |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Masking of outcome assessment was done by blinding observer as to the assignments to the study group |
| Selective reporting (reporting bias) |
Low risk |
All infants were included in final analysis |
| Other bias |
Unclear risk |
Protocol not available to compare |
