During infant vaccinations, only liposomal lidocaine provided consistent pain relief as part of a pain intervention, based on data from 352 infants.
“There is a dearth of data regarding the relative effects of combined interventions [for infants’ pain during vaccination] and their effectiveness over time,” wrote Anna Taddio, Ph.D., of the University of Toronto and her colleagues.
The researchers randomized 352 infants to one of four pain relief regimens to be used for all vaccinations during the first year of life: placebo control, parent-directed video education about infant soothing, the video plus oral sucrose, and the video plus sucrose plus topical lidocaine. The primary outcome of infant distress was assessed using the Modified Behavioural Pain Scale.
Overall, the mean pain scores were significantly lower in the video/sucrose/lidocaine group, compared with all other groups, and there were no significant differences in scores among the other groups.
“The observed treatment effect, albeit above the a priori threshold value set for clinical significance, may not be sufficiently compelling to clinicians to alter clinical practice, particularly in light of the short-lived nature of the pain,” the researchers said. However, “given that vaccination pain is iatrogenic and most infants were distressed despite the use of cointerventions, consideration should be given to adding lidocaine to reduce the burden of pain.”
Dr. Taddio disclosed a research grant from Pfizer, and materials for the study were supplied by Natus and Ferndale.
The findings were published online Dec. 12 in the Canadian Medical Association Journal (CMAJ 2016. doi: 10.1503/ cmaj.160542). Read the full study here.