Methods

Randomized controlled trial.
Blinding of randomization:
Yes
Blinding of intervention:
No
Complete follow‐up: Yes
Blinding of outcome: Can't tell

Participants

Healthy full term infants undergoing metabolic screening blood test (n = 60).
Demographic data: Values are presented as mean (SD) or percentage (%).
Venepuncture group: n = 30.
Birth weight (g) 3667 (449).
Gestational age (wks) 39.7 (1.4).
Gender (%) male 40.
Heel lance group: n = 30.
Birth weight (g) 3578 (465).
Gestational age (wks) 40.2 (1.2).
Gender (%) male 53.

Interventions

Venepuncture (n=30) versus heel lance (n=30).

Outcomes

Pain assessments were made using the duration of cry within the first 3 minutes after the skin puncture, the Premature Infant Pain Profile (PIPP) score and by changes in the heart rate.

Notes

Infants were randomized using a block randomization technique with sealed envelopes into one of the four groups ‐ HL and VP with and without oral administration of 1 ml of 30% glucose. Data on HL and VP group without the administration of glucose are included for this review.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

A ‐ Adequate

Methods

Randomized controlled trial.
Blinding of randomization:
Yes
Blinding of intervention:
No
Complete follow‐up: No
Blinding of outcome: No

Participants

Healthy full term infants undergoing PKU screening (n = 90).
Demographic data for the small caliber venepuncture needle group (n = 25) and the HL group (n = 29) are presented. Values are presented as mean (range) or percentage (%)
Small caliber venepuncture needle group; weight 3613 g (range 2690 ‐ 4740), gestational age (40, 37‐42), age 4 days (3‐6), male sex 44%; For the heel lance group (n = 29) weight 3525 g (2710 ‐ 4650), gestational age 39 weeks (37 ‐ 42), age 5 days (3 ‐ 6), male sex 66%

Interventions

Venepuncture with large caliber needle (n = 30) (results not reported). Small caliber venepuncture needle (n = 30; 5 infants excluded) versus heel lance (n = 30; 1 infant excluded).

Outcomes

NIPS (Neonatal Infant Pain Scale) reported at the beginning of each minute, the first minute starting at the moment of puncture. All infants were observed for a minimum of 5 minutes. Number of punctures were also noted.

Notes

Infants were randomized using consecutively numbered envelopes. No envelope was taken out of sequence. Data for the large caliber venepuncture needle group were not presented as in 33% of the infants the venepuncture was unsuccessful. 5 infants in the small caliber venepuncture needle group and 1 infant in the heel lance group were excluded from the analyses because more than two skin punctures were required

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

A ‐ Adequate

Methods

Randomized controlled trial.
Blinding of randomization: Yes
Blinding of intervention: No
Complete follow up: No
Blinding of outcome measurement: Yes

Participants

Healthy term infants undergoing blood testing for phenylketonuria (n=120).
Three infants in the small lancet group were excluded as one infant was of 35 weeks gestation and two infants screamed prior to heel lance.
Demographic data: Values are presented as median (range) or %.
Venepuncture group: n = 50.
Birth weight (g) 3410 (2440‐5035).
Gestational age (wks) 40 (36‐43).
Age (days) 3 (3‐7).
Gender (%) male 44.

Small lancet group: n = 47.
Birth weight (g) 3570 (2650‐4540).
Gestational age (wks) 40 (36‐43).
Age (days) 4 (3‐6).
Gender (%) male 55.

Large lancet group: n = 20.
Birth weight (g) 3398 (2160‐4330).
Gestational age (wks) 40 (37‐42).
Age (days) 4 (3‐7).
Gender (%) male 45.

Interventions

Venepuncture (n=50).
Heel lance with a small lancet (n=47).
Heel lance with a large lancet (n=20).
The authors do not explain the reasons for the unequal group sizes.

Outcomes

Pain assessments were made using Neonatal Facial Action Coding System (NFCS) and cry [latency (cry within 60 seconds of the skin puncture) and duration of first cry and total duration of cry]. Audiotapes were reviewed to determine the latency to cry from the skin puncture, duration of first cry and total time the infant cried during the procedure. Cry was defined as high‐pitched vocalization.

Notes

Infants were randomized using envelopes to receive VP, HL using a small lancet (SL) [three later excluded (one was a preterm infant and two infants screamed prior to heel lance)] or a large lancet (LL).
One investigator (neonatal nurse) performed all procedures.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

A ‐ Adequate

Methods

Randomized controlled trial.
Blinding of randomization: Yes
Blinding of intervention: No
Complete follow up: Yes
Blinding of outcome measurement: Can't tell

Participants

Healthy neonates of > =37 weeks gestational age (n=27).
Demographic data: Values are mean (SD) or number (%).
Heel lance group:
Age (days) 3.1 (1.1).
Gender (% male) 8 (57%).
State (% awake before procedure) 5 (36%).
Reason for test (% bilirubin) 13 (93%).

Venepuncture group:
Age (days) 2.8 (1.2).
Gender (% male) 8 (62%).
State (% awake before procedure) 7 (58%).
Reason for test (% bilirubin) 12 (97%).

Interventions

Venepuncture (n=13)
versus heel lance (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

Randomization was computer generated. Allocation was by sealed envelopes. One investigator (well‐trained pediatrician) performed all procedures. 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

Allocation concealment (selection bias)

Low risk

A ‐ Adequate