Table 3.
Primary and secondary outcomes: (a) incidence of severe oral mucositis and AUC for grade of OM, children’s and parents’ proxy ChIMES total and NRS for oral pain score; (b) opioid use during the neutropenic phase; (c) nutritional and infectious parameters during the neutropenic phase. OM oral mucositis, WHO-OTS WHO-Oral Toxicity Scale, ChIMES Children’s International Mucositis Evaluation Scale, NRS Numerical Rating Scale, TPN total parenteral nutrition
| Oral cryotherapy (n = 26) | Control (n = 23) | p value | |
|---|---|---|---|
| a. | |||
| Severe OM (grades 3–4), n (%) | 15 (57.7) | 11 (47.8) | 0.43 |
| Days with severe OM, mean (SD) | 3.2 (3.7) | 2.7 (4.2) | 0.68 |
| AUCa for WHO-OTS score (SD) | 21.2 (14.8) | 18.9 (15.6) | 0.61 |
| AUCa for ChIMES total children (SD) | 140.0 (128.5) | 174.9 (108.4) | 0.31 |
| AUCa for ChIMES total parents (SD) | 136.9 (105.8) | 176.2 (131.6) | 0.26 |
| AUCa for oral pain (NRS) children (SD) | 56.2 | 70.0 | 0.38 |
| AUCa for oral pain (NRS) parents (SD) | 59.1 | 74.1 | 0.33 |
| b. | |||
| Days with opioids (SD) | 8.4 (7.2) | 8.3 (7.2) | 0.34 |
| Total dose of opioidsb, mg (SD) | 168.1 (232.5) | 170.2 (271.1) | 0.98 |
| Total dose of opioidsb, mg/kg (SD) | 4.5 (6.7) | 5.0 (7.1) | 0.76 |
| c. | |||
| Weight change, kg (SD) | − 0.3 (2.4) | + 0.2 (1.4) | 0.38 |
| Days with TPN (SD) | 9.0 (8.9) | 6.6 (7.0) | 0.35 |
| Days with fever (SD) | 5.8 (5.8) | 3.2 (3.2) | 0.08 |
| Days on antibiotics (SD) | 12.7 (8.0) | 12.1 (5.6) | 0.75 |
aMean values day 0–24 after HSCT
bIV morphine equivalents