A randomized controlled trial of clinician-led tactile stimulation to reduce pain during vaccination in infants.

Background. Clinician-led tactile stimulation (rubbing the skin adjacent to the injection site or applying pressure) has been demonstrated to reduce pain in children and adults undergoing vaccination. Objective. To evaluate the analgesic effectiveness of clinician-led tactile stimulation in infants undergoing vaccination. Methods. This was a partially blinded randomized controlled trial that included infants undergoing vaccination in a private clinic in Toronto. Infants were randomly allocated to tactile stimulation or no tactile stimulation immediately prior to, during, and after vaccination. The primary outcome was infant pain, assessed using a validated observational measure, the Modified Behavioral Pain Scale (MBPS; range = 0-10). Results. Altogether, 121 infants participated (n = 62 tactile stimulation; n = 59 control); demographics did not differ (P>.05) between groups. MBPS scores did not differ between groups: mean = 7.2 (standard deviation = 2.4) versus 7.6 (1.9); P = .245. Conclusion. Tactile stimulation cannot be recommended as a strategy to reduce vaccination pain in infants because of insufficient evidence of a benefit.