Table 2: Participant characteristics (season of enrollment, demographics, febrile seizure risk, influenza vaccination information and doses of study medication received) according to treatment group.
| TREATMENT GROUP | ||||||
|---|---|---|---|---|---|---|
|
Acetaminophen (n=59) |
Ibuprofen (n=24) |
Placebo (n=59) |
Total (n=142) |
|||
| ENROLLMENT SEASON | ||||||
| n (%) | n (%) | n (%) | n (%) | |||
| 2013–2014a | 20 (33.9%) | 0 (0.0%) | 20 (33.9%) | 40 (28.2%) | ||
| 2014–2015b | 24 (40.7%) | 13 (54.2%) | 23 (39.0%) | 60 (42.2%) | ||
| 2015–2016b | 15 (25.4%) | 11 (45.8%) | 16 (27.1%) | 42 (29.6%) | ||
| DEMOGRAPHICS | ||||||
| Months | p-valuec | Months | p-valuec | Months | Months | |
| Age | ||||||
| Median | 24 | 0.77 | 28 | 0.42 | 24 | 24 |
| n (%) | p-value | n (%) | p-value | n (%) | n (%) | |
| Ethnicity | ||||||
| Hispanic | 9 (15.2%) | 0.39 | 1 (4.2%) | 0.67 | 5 (8.5%) | 15 (10.6%) |
| Race | ||||||
| White only | 23 (39.0%) | 0.35 | 11 (45.8%) | 0.81 | 29 (49.2%) | 63 (44.4%) |
| Black only | 22 (37.3%) | 0.70 | 9 (37.5%) | 0.80 | 19 (32.2%) | 50 (35.2%) |
| Other | 14 (23.7%) | 0.65 | 4 (16.7%) | 1.00 | 11 (18.6%) | 29 (20.4%) |
| Gender | ||||||
| Male | 30 (50.9%) | 1.00 | 13 (54.2%) | 0.35 | 29 (49.2%) | 72 (50.7%) |
| FEBRILE SEIZURE RISK | ||||||
| Participant history of FS |
3 (5.1%) | 0.62 | 2 (8.3%) | 0.20 | 1 (1.7%) | 6 (4.2%) |
| 1st degree relative with FS history |
5 (8.5%) | 0.76 | 1 (4.2%) | 0.43 | 7 (11.9%) | 13 (9.2%) |
| Participant or 1st
degree relative with FS history |
8 (13.6%) | 1.00 | 3 (12.5%) | 1.00 | 8 (13.6%) | 19 (13.4%) |
| INFLUENZA VACCINATION INFORMATION | ||||||
| Number of doses recommended | ||||||
| One dose | 53 (89.8%) | 0.58 | 20 (83.3%) | 1.00 | 50 (84.7%) | 123 (86.6%) |
| Two doses | 6 (10.2%) | ----- | 4 (16.7%) | 9 (15.3%) | 19 (13.4%) | |
| IIV type administered | ||||||
| IIV3 only | 24 (40.7%) | 1.00 | 1 (4.2%) | <0.01 | 23 (39.0%) | 48 (33.8%) |
| IIV4 only | 34 (57.6%) | 1.00 | 23 (95.8%) | <0.01 | 35 (59.3%) | 92 (64.8%) |
| IIV3 and IIV4 | 1 (1.7%) | 1.00 | 0 (0.0%) | 1.00 | 1(1.7%) | 2 (1.4%) |
| Dosage formulation administered | ||||||
| 0.25 mL | 50 (84.7%) | 0.39 | 13 (54.2%) | <0.01 | 54 (91.5%) | 117 (82.4%) |
| 0.5 mL | 9 (15.2%) | 0.39 | 10 (41.7%) | <0.01 | 5 (8.5%) | 24 (16.9%) |
| 0.25 mL and 0.5 mL | 0 (0.0%) | 1.00 | 1(4.2%) | 0.29 | 0 (0.0%) | 1 (0.7%) |
| NUMBER OF DOSES OF ANTIPYRETIC OR PLACEBO ADMINISTERED | ||||||
| <3 | 6 (10.2%) | 1.00 | 2 (8.3%) | 1.00 | 6 (10.2%) | 14 (9.9%) |
| ≥3 | 53 (89.8%) | ----- | 22 (91.7%) | ----- | 53 (89.8%) | 128 (90.1%) |
a
Pilot Study,
b
Expanded Study,
c
Fisher’s exact test for categorical data and Wilcoxon rank sum tests for medians. All statistical comparisons were between acetaminophen and placebo groups or ibuprofen and placebo groups.