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

Table 3 Adverse events at 5 minutes and 15 minutes after vaccination (intention-to-treat population), n (%)

Adverse event (CTCAE v5.0, grade 1 unless noted)	Group A	Group B	Risk ratio (B/A), 95%CI	P value
At 5 minutes after injection
Pain	42 (56.8)	39 (51.3)	0.90 (0.67-1.22)	0.517
Swelling	0 (0.0)	1 (1.3)	Not estimable	> 0.999
Bruising/ecchymosis	0 (0.0)	0 (0.0)	Not estimable	> 0.999
Erythema	9 (12.2)	4 (5.3)	0.43 (0.14-1.34)	0.156
Pruritus	13 (17.6)	6 (7.9)	0.45 (0.18-1.12)	0.089
Anaphylaxis	0 (0.0)	0 (0.0)	Not estimable	> 0.999
Any event	52 (70.3)	43 (56.6)	0.81 (0.63-1.03)	0.092
At 15 minutes after injection
Pain	23 (31.1)	13 (17.1)	0.55 (0.30-1.00)	0.056
Swelling	1 (1.4)	2 (2.6)	1.95 (0.18-21.02)	> 0.999
Bruising/ecchymosis	1 (1.4)	1 (1.3)	0.97 (0.06-15.28)	> 0.999
Erythema	12 (16.2)	7 (9.2)	0.57 (0.24-1.36)	0.227
Pruritus	7 (9.5)	3 (3.9)	0.42 (0.11-1.55)	0.206
Anaphylaxis	0 (0.0)	0 (0.0)	Not estimable	> 0.999
Swelling and erythema combined	1 (1.4)	2 (2.6)	1.95 (0.18-21.02)	> 0.999
Any event	34 (45.9)	19 (25.0)	0.54 (0.34-0.86)	0.010

P values from Fisher’s exact tests. Risk ratios are presented as group B/group A with 95% confidence intervals calculated by the log-normal approximation; values below 1.00 indicate a lower risk in group B. Risk ratios are not estimable when one or both cells contain zero events. All adverse events were Common Terminology Criteria for Adverse Events grade 1 (mild) and self-resolving. CTCAE: Common Terminology Criteria for Adverse Events; CI: Confidence interval.