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. 2016 Jul 15;2016(7):CD001069. doi: 10.1002/14651858.CD001069.pub5

6. Trials assessing pain during intramuscular injection (immunization for hepatitis B or vitamin K injection).

Study Participants Procedure Interventions Outcomes Metrics used Results
Gray 2012 47 healthy full‐term infants Immunization for hepatitis B

  1. Sucrose (n = 15)

  2. Warmth (n = 14)

  3. NNS with pacifier (n =15)


3 infants were subsequently excluded from data analysis (1 in the sucrose group and 2 in the warmth)		 Cumulative crying time (s)
Mean HR
Mean respiratory sinus arrhythmia
Cumulative distribution of grimace time		 Graphs only Infants in the warmth group cried significantly less than those in the sucrose or NNS groups after vaccination. HR patterns reflected this analgesia. Core temperature did not differ between study groups. "Providing natural warmth to newborn infants during a painful procedure decreases the crying and grimacing on par with the 'gold' standard treatments of sucrose or pacifier" (Gray 2012).
No data could be used in RevMan‐analyses
Gray 2015 29 healthy, full‐term newborns Immunization for hepatitis B

  1. Sucrose group: 0.24 g sucrose (1 mL 24% sucrose solution, Sweet‐Ease) (n = 15)

  2. Sucrose + warmth group: sucrose as above and exposed to warmth (n = 14)

 Duration (s)of grimace and cry Means and SDs The sucrose + warmth group cried significantly less 12.8 s (SD 2.2) vs. 28.0 s (SD 6.9) and grimaced less 14.9 s (SD 2.4) vs 31.1 s (SD 7.2) than the sucrose only group
Data included in RevMan‐analyses
Liaw 2011 165 healthy newborn infants
PMA ≥ 36 weeks and birthweight ≥ 2200 g		 Immunization for hepatitis B

  1. 22% sucrose orally (n = 55)

  2. Routine care (n = 55)

  3. NNS (n = 55)

 NFCS
Cry duration
HR
RR		 Cry duration (s) was reported as mean (SD)
Other outcomes reported in graph form or in multiple regression models		 Pain was significantly lower among infants in the NNS (P < 0.001) and sucrose (P < 0.001) groups than that in the routine care group after adjusting for time effects, infant sleep/wake state, number of prior painful experiences, and baseline pain scores. Infants in the NNS and sucrose groups had significantly lower mean HR and RR than the controls. Cry duration of infants receiving sucrose was significantly shorter than those in the NNS (P < 0.001) and routine care groups (P < 0.001)
Data for cry duration included in RevMan‐analyses
Suhrabi 2014 90 full‐term neonates Immunization for hepatitis B

  1. Sucrose group (n = 30): 2 mL oral sucrose (25%) through a syringe in 30 s

  2. Glucose group (n = 30): 2 mL oral glucose (25%) through a syringe in 30 s

  3. Control group (n = 30): no intervention


Solutions applied 2 min before hepatitis B vaccination		 NIPS during 1‐2 min after vaccination Mean, SD Comparison of pain severity, mean and SD of pain, showed greater intensity of pain in the glucose group than the sucrose group (3 ± 1.66 vs. 2.90 ± 1.44), but this difference was not significant statistically (P = 0.78). Pain intensity was higher in the control group than in the intervention groups (P < 0.001)
NIPS during 1‐2 min after vaccine injection were used in RevMan‐analyses

Abbreviations

HR = heart rate
 NFCS = Neonatal Facial Coding System
 NIPS = Neonatal Infant Pain Scale
 NNS = non‐nutritive sucking
 PMA = postmenstrual age
 RR = respiratory rate
 SD = standard deviation