Goswami 2013.

Study characteristics
Methods	Randomised controlled trial at a single site (immunisation clinic) in India
Participants	120 infants ages 6 weeks to 3 months Painful procedure: wDPT vaccination Study period: Not specified
Interventions	Intervention 1: Breastfeeding before and during vaccination Intervention 2: 2 mL of 25% dextrose given orally 2 minutes prior to vaccination Control: 2 mL of distilled water given orally 2 minutes prior to vaccination
Outcomes	Cry duration from time of needle insertion until a period of silence of more than 5 seconds, up to a maximum of 3 minutes (presented as median and IQR but converted to mean and standard deviation for meta‐analysis) Latency of onset of cry (the time from needle insertion to onset of vocalisation of cry) MFCS at time of needle insertion, 1 minute after needle insertion, and 3 minutes after needle insertion (presented in graphical form only)
Notes	Power calculation: Yes (p. 650)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"The subjects were randomised into three groups of 40 each through computers generated random numbers and put in serially numbered opaque sealed envelopes (SNOSE method)." (p. 649) Sequence generated using computer‐generated random numbers.
Allocation concealment (selection bias)	Low risk	"The subjects were randomised into three groups of 40 each through computers generated random numbers and put in serially numbered opaque sealed envelopes (SNOSE method)." (p. 649) Serially numbered, opaque, sealed envelopes used.
Blinding of participants and personnel (performance bias) All outcomes	High risk	"Babies in breastfed group were breastfed throughout the intervention, starting 2 minutes prior to the vaccination; 25% dextrose group: 2 ml of 25% dextrose was given orally by a sterile syringe 2 minutes prior to intramuscular vaccination; Placebo group: 2 ml distilled water was given orally by a sterile syringe 2 minutes prior to intramuscular vaccination." (p. 65) Personnel could not be blinded to whether or not infant was breastfeeding.
Blinding of outcome assessment (detection bias) All outcomes	High risk	"All events were recorded by the investigator on a digital video camera (model Sony CCDTRV238E) for total duration of three minutes from the removal of the needle." (p. 650) The researcher completing the cry duration and MFCS could not be blinded to whether the infant was breastfeeding or not.
Incomplete outcome data (attrition bias) All outcomes	Low risk	"120 babies were randomised into 3 groups of 40 babies each." (p. 650) Outcome data reported for all 120 randomised infants.
Selective reporting (reporting bias)	Unclear risk	Study protocol not registered in trial registries searched.
Sample size	High risk	Fewer than 50 infants per arm.
Other bias	Low risk	Appears free of other bias.