Shah 1997.
Methods | Randomized controlled trial Blinding of randomisation: Can't tell Blinding of intervention: No Complete follow up: Yes Blinding of outcome measurement: No | |
Participants | Healthy neonates of > =37 weeks PMA (n=27)
Demographic data: Values are mean (SD) or number (%) HL group: Age (days) 3.1 (1.1) Sex (% male) 8 (57%) State (% awake before procedure) 5 (36%) Reason for test (% bilirubin) 13 (93%) VP group: Age (days) 2.8 (1.2) Sex (% male) 8 (62%) State (% awake before procedure) 7 (58%) Reason for test (% bilirubin) 12 (97%) |
|
Interventions | VP (n=13) HL (n=14) 0.25 ml of blood was obtained with either method | |
Outcomes | Pain assessments were made using Neonatal Infant Pain Scale (NIPS) Parental rating of their own anxiety was assessed using a three point scale where 0= not worried at all, 1= a little worried and 2= very worried and infant's pain using a scale where 0= no pain at all, 1= a little pain and 2= a lot of pain | |
Notes | One investigator (well‐trained paediatrician) performed all procedures One infant in each group had the procedure performed while being breat fed One of the reviewers (V. Shah) for this systematic review is the primary author of this paper | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding (performance bias and detection bias) All outcomes | High risk | Personnel knew group assignment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported for all 27 infants included |
Selective reporting (reporting bias) | Unclear risk | The study was not registered in a trials registry |
Other bias | High risk | The study was stopped after 27 infants had been enrolled from the preset sample of 50 infants |