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.
RCT Entities:
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 infantpain, 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.