| Methods |
Design: three group parallel trial
Purpose: examine the analgesic effect of glucose, sucrose and pacifiers in term infants |
| Participants |
Patients: newborn infants in need of venipunctures
Baseline comparability: yes |
| Interventions |
Placebo: 2 minutes before venipuncture sterile water was given to the infant orally with a syringe for 30 seconds
Untreated: no sugar, pacifier or water
Experimental:
‐glucose in syringe
‐sucrose in syringe
‐pacifier
‐sucrose in syringe and pacifier
(Co‐intervention: no) |
| Outcomes |
Pain (Douleur Aiguë du Nouveau‐né (DAN) scale (0 to 10 points)) during venipuncture |
| Notes |
Outcome reported as medians (both placebo and no treatment: 7) and interquartile ranges (6‐10, and 5‐10)). Individual results were reported, and we recalculated the outcome as means and SD |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
‘random numbers table' |
| Allocation concealment? |
Low risk |
‘treatment allocations inserted in opaque sealed envelopes numbered 1‐150. Investigators were blind to these allocations.' |
| Blinding?
Treatment provider |
Unclear risk |
NS |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
Low risk |
N = 50 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
