Clinical Context

One of the main barriers to timely immunizations in children is the parents' concern about the associated pain and discomfort, as reported by Jacobson and colleagues in the March 21, 2001, issue of Vaccine. In the December 14, 2010, issue of the Canadian Medical Association Journal, Taddio and colleagues noted that concentrated sucrose alone is effective for pain control in infants receiving immunizations. Breast-feeding, which combines comforting, skin-to-skin contact, distraction, and the sweetness of lactose, is another effective method of analgesia, as reported by Shah and colleagues in the June 2007 issue of Breastfeeding Medicine. In The Happiest Baby on the Block, published in 2003, Karp described a calming intervention called the 5 S's: swaddling, side or stomach position, shushing, swinging, and sucking.

This prospective, randomized, placebo-controlled trial by Harrington and colleagues assesses whether sucrose water alone, physical intervention with the 5 S's alone, or sucrose water plus physical intervention are effective forms of analgesia for infants receiving immunizations.

Study Synopsis and Perspective

Infant immunizations are stressful for parents and painful for recipients. A study published in the May issue of Pediatrics found that the pain-reducing effect of a physical intervention with or without sucrose water was superior to sucrose water alone.

Evidence is scant that a pain reliever such as acetaminophen is effective postvaccination, and this drug may dampen the antibody response to certain vaccine antigens. To investigate a nonpharmacological intervention to alleviate injection pain, John W. Harrington, MD, from the Department of Pediatrics, Eastern Virginia Medical School, and Department of Pediatrics, Section of General Academic Pediatrics, Children's Hospital of The King's Daughters, Norfolk, Virginia, and colleagues conducted a prospective, randomized, placebo-controlled trial to test an intervention termed the "5 S's," for swaddling, side/stomach position, shushing, swinging, and sucking.

The researchers divided 230 infants being immunized at 2- or 4-month well-baby check-ups into 4 groups that received either 2 mL of water or 2 mL of a 24% sucrose solution 2 minutes before vaccination, and either standard comfort care from the parent or guardian or a 5 S's intervention from a researcher. Sucrose is added to acetaminophen products to improve palatability, and in some studies appeared to relieve pain.

The investigators used the Modified Riley Pain Score (cry quality, grimace, movement) to assess pain every 15 seconds for 2 minutes, and subsequently every 30 seconds for up to 5 minutes after vaccination. A 1-way analysis of variance evaluated mean pain across groups over time, and repeated-measure general linear modeling evaluated pain scores at each interval across the groups. The vaccines were for rotavirus and hepatitis B, injected intramuscularly into the thigh.

Pain scores ranged from 0 to 9. Mean pain scores were 4.46 for the control group (water, parental comfort), 3.95 for the sucrose group (sucrose, parental comfort), 3.24 for the physical group (water, 5 S's), and 3.61 for the physical with sucrose group (sucrose, 5 S's). The difference in mean pain scores was significantly lower in all treatment groups compared with the control group, and the mean pain score for the 5 S's–only group was significantly less than the sucrose group. However, the difference between the two 5 S's groups was not statistically significant.

The 2 groups implementing the 5 S strategy had less pain and shorter duration of crying than the 2 groups without the strategy, and the 5 S intervention was about equally effective with or without sucrose. The researchers conclude, "The 5 S's appear to be a viable nonpharmacologic option for clinics to implement when providing analgesia during vaccinations." In addition to minimizing suffering, pain control during immunizations may calm parents who are hesitant to have their children vaccinated, the researchers point out.

Limitations of the study include that the 3 researchers who provided the 5 S's might have differed slightly in their technique, the disproportionate number of 2-month-olds, and the difficulty of assessing movements to evaluate pain in a swaddled baby. Finally, the parents may have been providing the 5 S's as well.

The authors have disclosed no relevant financial relationships.

Pediatrics. 2012;129:815-822.

Clinical Implications

• In infants receiving immunizations, the pain scores are lowest in those who either receive physical intervention alone or physical intervention with sucrose water, followed by receipt of sucrose water alone, and lastly no specific intervention (control).
• In infants receiving immunizations, the proportion of children crying as time progressed is lowest in those who receive physical intervention alone or physical intervention with sucrose water, followed by receipt of sucrose water alone, and lastly no specific intervention (control).

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