Table 4.
Child Pain and Analgesic Outcomes in the Groups (tallied from daily diaries and surveys)
| Control n=292 | STOMP n=271 | Odds Ratio or Mean Difference [95% CI] | |
|---|---|---|---|
| Opioid given at home (yes vs. no) | 240 (81.1%) | 216 (79.1%) | 0.88 [0.59, 1.34] |
| Opioid doses dispensed | 21.5 ± 13.76 | 22.0 ± 16.48 | 0.50 [−1.95, 2.96] |
| Opioid doses given at home (total) | 7.9 ± 8.6 | 8.6 ± 10.3 | 0.71 [−0.87, 2.28 |
| Opioid meq/kg given | 0.20 ± 0.23 | 0.21 ± 0.26 | 0.01, [−0.33, 0.05] |
| Days opioid given | 3.31 ± 3.2 | 3.80 ± 4.2 | 0.49 [−0.13, 1.12] |
| OTC doses given | 20.2 ± 16.0 | 19.7 ± 15.3 | −0.45 [−3.06, 2.16] |
| Days OTC given | 7.6 ± 4.6 | 7.8 ± 5.2 | 0.18 [−0.63, 1.00] |
| Days 8 to14 | 3.2 ± 1.9 | 3.5 ± 2.3 | 0.30 [−0.23, 0.83] |
| Parent-reported Pain Interference Score Day 14 | 8.06 ± 8.06 | 8.63 ± 8.39 | 0.57 [−0.68, 1.82] |
| Adverse events (yes vs. no) | |||
| Nausea (requiring intervention) | 34 (14.2%) | 23 (9.9%) | 0.66 [0.38, 1.17] |
| Constipation (requiring intervention) | 105 (46.3%) | 106 (47.5%) | 1.05 [0.73, 1.52] |
| Moderate to severe sedation | 45 (19.1%) | 37 (15.9%) | 0.80 [0.49, 1.29] |
| Serious adverse events* | 10 (3.4%) | 9 (3.3%) | 0.93 [0.37, 2.33] |
Data shown as n (%) or mean ± standard deviation. Univariate comparisons were made using Chi-square or unpaired t-tests. Unadjusted odds ratios are shown.
Meq/kg=Morphine equivalents per kilogram; OTC=Over-the-counter;
*
serious adverse events include those that led to a call or unplanned return visit to the clinic or hospital setting as determined by medical record review. Other adverse effects were reported by parents on their daily diaries; percentages were calculated from those who reported events.