Reducing immunization discomfort in 4- to 6-year-old children: a randomized clinical trial.

The goal was to test a multifaceted distraction method designed to reduce injection-associated pain in school-aged children. A clinical trial evaluated 41 children, 4 to 6 years of age, who were given 3 standard prekindergarten immunizations; 21 were assigned randomly to an office routine control group, whereas 20 received a multifaceted, discomfort-reducing intervention. The intervention added verbal suggestions of diminished sensation and a visual focusing activity to the use of ethyl chloride, an established pain-reducing measure. The distraction materials used for the intervention consisted of topical ethyl chloride spray, an improvised, plastic, multipronged arm gripper, and a vibrating instrument descending on the contralateral arm, which provided the focusing task and visual distraction. According to patient and parent Faces Pain Scale-Revised scores and nonblinded, video-taped observations scored according to the face-legs-activity-crying-consolability method, the intervention group showed highly significant reductions in pain and discomfort, compared with the control group (patient self-report, P < .0013; parent report, P < .0002; observation score, P < .0001). This multifaceted distraction intervention reduced significantly the pain and discomfort of childhood immunizations in children 4 to 6 years of age.