2. Trials assessing pain during intramuscular injection.

Study	Design	Participants	Intervention	Outcome	Metrics Used	Results
Chermont 2009	RCT	640 infants (160 skin‐to‐skin care, 160 control, 160 comparison1, 160 comparison2) Postnatal age, mean ± SD, hrs: 293 ± 13 (skin‐to‐skin care), 29 ± 15 (control), 29 ± 13 (comparison1), 27 ± 13 (comparison2) postmenstrual age, mean ± SD, wk: 39 ± 1 (for all groups) Birth weight, mean ± SD, g: 3164 ± 371 (intervention); 3163 ± 418 (control); 3252 ± 389 (comparison1); 3240 ± 418 (comparison2)	Intervention: skin‐to‐skin contact, initiated 2 minutes before injection and persisting throughout procedure Control: standard care during injection Comparison1: oral 25% dextrose treatment (1 mL), given 2 minutes before injection Comparison2: combination of oral dextrose treatment and skin‐to‐skin contact strategies. Provider: mother provided skin‐to‐skin; oral dextrose provided by nurse or neonatologist.	Neonatal Facial Coding System (NFCS), Neonatal Infant Pain Scale (NIPS), and Premature Infant Pain Profile (PIPP) scores at baseline, cleansing, injection, and recovery	Mean, standard error	NFCS and NIPS scores for the 4 groups at the 4 study times showed that main effect of time and analgesic procedures were statistically significant (P < 0.001), as was interaction between time and procedure (P < 0.001). Either skin‐to‐skin contact or 25% dextrose treatment alone did not significantly affect pain scores during injection, but the combination of both significantly decreased these scores during the invasive procedure. Mean PIPP scores showed significant differences among groups (P < 0.001). PIPP scores were lower when IM vaccine injections were given to healthy neonates during skin‐to‐skin contact with their mothers, regardless of whether oral 25% dextrose treatment was administered. Isolated use of the sweetener did not decrease PIPP scores, compared with standard care. Heart rate and oxygen saturation variability (not defined) were reported significantly to favour of SSC over both control and sucrose.
Kostandy 2013	Randomized controlled trial	36 term infants (Gestational Age, mean, weeks = 39.6) Postnatal age, mean, hours = Intervention: 24.29; Control: 28.35 Birth weight mean ± SD, grams: Intervention: 3389.7 ± 333.3; Control: 3326.8 ± 324.08	Intervention: skin‐to‐skin for 10‐15 minutes before, and during IM injection. Control: supine in bassinet 10 to 15 minutes before IM injection. Provider: mother	Cry time, behavioural state, heart rate	means, standard deviations	neonates in skin‐to‐skin group had shorter cry time during recovery (16 vs 72 seconds, P = 0.007), calmer behavioural state (2.82 vs 6.47 time points to reach non‐crying state P = 0.005)
Saeidi 2010	RCT	60 full‐term infants (80% of case group and 73.3% of control group had 40 weeks GA) Birth weight, mean ± SD, grams: 3242 ± 306.6 (intervention), 3151 ± 331.5 (control)	Intervention: 30 minutes skin to skin contact Control: standard care during injection Provider: mother provided skin‐to‐skin care	Behavioural changes using the Neonatal/Infant Pain Scale (NIPS) 2 minutes before, during, and 3 minutes after intervention heart rate oxygen saturation	NIPS: number (%) O₂ saturation: mean, SD HR and crying interval: P values	Mean pain intensity during the intervention was significantly lower in the case group (P < 0.006). Mean pain intensity 3 minutes after intervention was also significantly lower in the case group (P < 0.021). Mean duration of crying was significantly lower in the case group as well (P < 0.001)
Sajedi 2007	RCT	100 infants (50 intervention, 50 control) Postmenstrual age, mean ± SD, weeks: 39.36 ± 1.45 (intervention), 39.12 ± 1.42 (control) Birth weight, mean ± SD, grams: 3083.2 ± 258.33 (intervention), 3142.2 ± 242.3 (control)	Intervention: 10 minutes of skin‐to‐skin care before and during painful procedure, and 3 minutes after injection Control: standard care during injection Provider: mother provided skin‐to‐skin care	Neonatal Infant Pain Scale (NIPS), Behavioural responses (facial expression, breathing pattern, state of arousal, arm and leg movements, and cry), heart rate and oxygen saturation before, during and after injection	Mean, standard deviations, Chi², degrees of freedom	Significantly more severe behavioural responses immediately after injection in control than intervention group (P < 0.001). NIPS scores immediately after injection significantly higher in control than intervention group (P < 0.001). Duration of crying post‐injection significantly longer in control than intervention group (P = 0.001). No significant difference in mean heart rate before injection (P = 0.4) but during (P < 0.001), and after (P < 0.001) injection, favouring the KC group. No significant difference in the blood oxygen saturation before (P = 0.7) but during (P < 0.001) and after (P < 0.001) injection between the 2 groups, favouring the KC group