Secondary pain outcomes during 2-, 4-, 6- and 12-month vaccinations
| Characteristic | Mean ± SD* | |||
|---|---|---|---|---|
| Placebo control n = 88 | Video n = 88 | Video–sucrose n = 87 | Video–sucrose–lidocaine n = 87 | |
| At 2 mo | ||||
| Parent numeric rating scale† | 7.1 ± 1.9 | 7.3 ± 2.1 | 7.0 ± 2.0 | 6.4 ± 2.3 |
| Physician numeric rating scale‡ | 6.1 ± 1.7 | 6.3 ± 1.7 | 6.0 ± 1.6 | 5.5 ± 2.0 |
| Observer Modified Behavioural Pain scale‡ | 8.1 ± 1.2 | 8.3 ± 1.1 | 8.0 ± 1.3 | 7.7 ± 1.3 |
| Cry duration, s§ | 23.2 ± 6.1 | 22.9 ± 5.9 | 22.5 ± 6.1 | 21.4 ± 6.9 |
| No pain, no. (%)¶ | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Parent satisfaction§ | 3.7 ± 1.1 | 3.9 ± 1.0 | 3.8 ± 1.0 | 3.9 ± 1.1 |
| At 4 mo | n = 82 | n = 78 | n = 78 | n = 76 |
| Parent numeric rating scale† | 5.6 ± 2.0 | 5.2 ± 2.2 | 4.8 ± 2.5 | 4.3 ± 2.1 |
| Physician numeric rating scale‡ | 7.3 ± 2.5 | 4.5 ± 2.0 | 4.5 ± 2.1 | 4.0 ± 1.9 |
| Observer Modified Behavioural Pain Scale‡ | 5.1 ± 1.9 | 6.9 ± 1.5 | 6.8 ± 1.6 | 6.4 ± 1.5 |
| Cry duration, s§ | 18.1 ± 7.4 | 16.0 ± 7.5 | 15.3 ± 8.1 | 14.4 ± 7.0 |
| No pain, no. (%)¶ | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Parent satisfaction§ | 4.2 ± 0.9 | 4.3 ± 1.0 | 4.3 ± 0.9 | 4.5 ± 0.9 |
| At 6 mo | n = 81 | n = 75 | n = 79 | n = 74 |
| Parent numeric rating scale† | 2.6 ± 2.7 | 2.2 ± 2.6 | 3.1 ± 2.6 | 1.8 ± 2.4 |
| Physician numeric rating scale‡ | 2.1 ± 2.2 | 1.9 ± 2.0 | 2.3 ± 2.2 | 1.8 ± 2.5 |
| Observer Modified Behavioural Pain Scale‡ | 5.1 ± 2.3 | 4.5 ± 2.0 | 5.2 ± 2.2 | 4.4 ± 2.2 |
| Cry duration, s§ | 7.9 ± 9.5 | 6.0 ± 8.4 | 7.8 ± 8.7 | 6.0 ± 9.7 |
| No pain, no. (%)¶ | 14 (17.3) | 19 (25.3) | 15 (19.0) | 22 (29.7) |
| Parent satisfaction§ | 4.7 ± 0.6 | 4.7 ± 0.7 | 4.7 ± 0.8 | 4.7 ± 0.7 |
| At 12 mo | n = 76 | n = 75 | n = 77 | n = 71 |
| Parent numeric rating scale† | 4.8 ± 2.7 | 5.4 ± 2.9 | 5.5 ± 2.7 | 4.8 ± 3.0 |
| Physician numeric rating scale‡ | 4.4 ± 2.3 | 4.9 ± 2.3 | 4.9 ± 2.3 | 4.2 ± 2.5 |
| Observer Modified Behavioural Pain Scale‡ | 6.8 ± 2.0 | 7.0 ± 1.9 | 7.1 ± 2.0 | 6.6 ± 2.2 |
| Cry duration, s§ | 18.3 ± 10.0 | 19.3 ± 10.2 | 19.9 ± 9.8 | 17.3 ± 10.8 |
| No pain, no. (%)¶ | 0 (0) | 1 (1.3) | 0 (0) | 0 (0) |
| Parent satisfaction§ | 4.2 ± 1.1 | 4.1 ± 1.2 | 4.1 ± 1.0 | 4.3 ± 1.0 |
Note: SD = standard deviation.
↵* Unless otherwise specifiied.
↵† Analysis of variance showed a group–time interaction (p = 0.03) for parent numeric rating scale; scores differed between the video–sucrose–lidocaine group and placebo and video at 2 and 4 months. The video–sucrose group differed from placebo at 4 months. The video–sucrose group differed from the video and the video–sucrose–lidocaine groups at 6 months.
↵‡ Analysis of variance showed time (p < 0.001) and group effects for physician numeric rating scale (p = 0.02), and observer Modified Behavioural Pain Scale (p = 0.004); scores were lower (p < 0.05 for all comparisons) for the video–sucrose–lidocaine group compared with other groups. There were no other between-group differences.
↵§ Analysis of variance showed a time effect (p < 0.001) for cry and satisfaction scores, but no group effects; p = 0.05, and p = 0.5, respectively.
↵¶ Cochran–Mantel–Hansel did not show a group effect (p = 0.2) for frequency of infants with no pain.