The aim of the study was to determine the efficacy of ShotBlocker (Bionix, Toledo, Ohio) in reducing pediatric pain with intramuscular (IM) injections.

A prospective randomized controlled trial was conducted in children aged 2 months to 17 years who required an IM injection. Children were randomized to the no-intervention group or the ShotBlocker group. Demographic data and the number of IM injections were recorded. Perceived pain scores were obtained from nurses and caregivers using a 6-point Likert-type scale. Baker Wong Faces scale was used in children 36 months or older. Difficulty using the device was also rated by nurses on a 6-point scale.

One hundred sixty-five children were enrolled with 80 in the no-intervention arm and 85 in the ShotBlocker arm. The mean age of children was 45 months and 56% were male. Perceived pain scores by nurses were higher for the no-intervention group (2.6 vs 1.8, P < .001) as well as by caregivers (2.6 vs 2.1, P = .04). Children aged 36 months and older (n = 64) did not report a difference in pain scores (1.5 vs 1.3, P = .6); however, in a subgroup of children 72 months or older, pain scores trended higher in the no-intervention group (1.3 vs 0.5, P = .051). Nurse-perceived difficulty of ShotBlocker use was low 1.39 (±1.1).

Nurses and caregivers noted lower pain scores in children assigned to the ShotBlocker group. These differences were not as evident when children rated their own pain.