Randomized controlled trial of topical EMLA and vapocoolant spray for reducing pain during wDPT vaccination

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Randomized controlled trial of topical EMLA and vapocoolant spray for reducing pain during wDPT vaccination Navratan Kumar Gupta, Amit Upadhyay, Ajeet Kumar Dwivedi, Astha Agarwal, Vijay Jaiswal, Abhishek Singh Meerut, India babies receiving only breast feeding (BO group) [67.5 (27.6-180) seconds] (P=0.147). Difference in median (IQR) of latency of cry was not statistically significant. Modified Facial Coding Score and Neonatal Infant Pain Scale at 1 minute and 3 minutes was significantly lower in the EB and VB group, as compared to the BO group (P0.05 Age (mon) 1.7 (0.34) 1.6 (0.45) 1.9 (0.40) >0.05 Weight (kg) 4.3 (0.83) 4.3 (0.63) 4.4 (0.70) >0.05 Length (cm) 54.1 (4.2) 54.6 (3.6) 54.6 (4.4) >0.05 Head circumference (cm) 37.2 (1.7) 37.6 (1.5) 37.6 (1.5) >0.05 Time since last feed (min) 54.2 (16.7) 54.5 (29.4) 50.3 (17.0) >0.05 Duration of needle insertion (s) 3.6 (0.37) 3.7 (0.45) 3.7 (0.45) >0.05 Values are presented as mean (standard deviation). *: Data are reported as number with the corresponding percentage in parentheses. EB: babies receiving EMLA cream with breast feeding; VB: babies receiving vapocoolant spray with breast feeding; BO: babies receiving only breast feedingbabies receiving only breast feeding.

Out of the total of 201 eligible participants, 111 babies were excluded for various reasons (Fig. 1) and 90 babies were randomized and analyzed in three groups of 30 each. The baseline characteristics of the three groups were comparable (Table 1). Duration of cry The median (IQR) duration of cry was 35.86 (21.07107.75) seconds in the EB group, followed by 32.58 (21.25-106.21) seconds in the VB group as compared with 67.5 (27.6-180) seconds in the BO group. This difference was not statistically significant (P=0.147) (Fig. 2). Latency of onset of cry The median (IQR) latency of cry in the EB, VB, and BO groups was 1.26 (1.06-1.8), 1.84 (1.25-2.21) and 1.48 (1.13-1.92) seconds, respectively (P>0.05). MFCS At 1 minute and 3 minutes, MFCS was significantly lower in the EB and VB groups babies as compare with the BO group (P0.05) (Table 2). NIPS At 1 minute and 3 minutes, NIPS was significantly lower in the EB and VB groups babies as compare to BO group (P