Shortened eutectic mixture of lidocaine and prilocaine plus skin cooling for pediatric vaccination pain: A randomized non-inferiority trial

Table 1 Baseline demographic and clinical characteristics of participants (intention-to-treat population, n = 150), n (%)/median (interquartile range)

Characteristic	Group A: EMLA 40 minutes (n = 74)	Group B: EMLA 20 minutes + cooling (n = 76)	P value
Child characteristics
Age (year)	8.50 (6.33-10.67)	8.46 (6.25-10.46)	0.870
Male sex	27 (36.5)	30 (39.5)	0.830
Weight (kg)	26.00 (20.62-42.75)	25.35 (20.00-39.25)	0.680
Height (cm)	127.50 (116.00-149.25)	128.25 (117.75-138.12)	0.970
BMI (kg/m2)	16.59 (14.49-19.62)	15.48 (14.18-18.26)	0.270
Overweight or obese	21 (28.4)	17 (22.4)	0.510
Obese	12 (16.2)	10 (13.2)	0.770
Allergy1	4 (5.4)	5 (6.6)	> 0.999
Underlying condition2	18 (24.3)	21 (27.6)	0.780
Fear of needles	26 (35.1)	31 (40.8)	0.590
Family characteristics
Parental report of fear of needles	8 (10.8)	11 (14.5)	0.670
Parent’s education ≥ Bachelor’s degree	67 (90.5)	63 (82.9)	0.260
Number of siblings	2.0 (2.0-2.0)	2.0 (1.0-2.0)	0.520
Caregiver present at injection	62 (83.8)	66 (86.8)	0.770

¹Allergy includes parental report of allergy to drug (e.g., cefaclor, amoxicillin), seafood, cow’s milk, egg, or mixed allergens.

²Underlying conditions include asthma, atopic dermatitis, chronic eczema, allergic rhinitis, congenital heart disease, attention-deficit/hyperactivity disorder, obstructive sleep apnoea, thalassaemia or single kidney.

P values are from Mann-Whitney U tests for continuous variables and Fisher’s exact tests for categorical variables. EMLA: Eutectic mixture of lidocaine and prilocaine; BMI: Body mass index.