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Sleep adjustment avoided sedation in most pediatric radiotherapy fractions

A structured sleep protocol enabled sedation-free delivery in 96.4% of radiotherapy fractions among children younger than four years.

RadOncToday · ·1 min read

KEY POINTS

  • This single-centre pragmatic randomized phase II feasibility trial enrolled 48 children aged 0–4 years with non-head-and-neck solid tumours. Participants were randomized 2:1 to the WASPE sleep-adjustment protocol or standard chloral-hydrate sedation.
  • WASPE used videos, outdoor activities, stimulation, toys, and snacks to keep children awake before treatment. Families began the protocol three days before radiotherapy, targeting sleep from 22:00–23:00, waking at 06:00–07:00, and spontaneous sleep during treatment at 14:00–16:00.
  • All patients received image-guided IMRT with pretreatment CBCT and real-time optical surface monitoring. Treatment was interrupted when motion exceeded 5 mm and failed to self-correct; CT simulation was still performed under pharmacologic sedation.
  • In the WASPE arm, 432 of 448 fractions (96.4%) were completed without sedation. The model-estimated success rate was 96.2% (95% CI 93.3–97.9%), meeting the prespecified feasibility criterion because the lower confidence limit exceeded 93%.
  • Twenty-one of 32 children (65.6%) completed every fraction without sedation. The remaining 11 children required sedation for only 16 fractions, mainly during the first one to three treatments while adapting to the protocol.
  • Interpretation of the randomized comparison was weakened by substantial crossover: 7 of 16 control patients used WASPE for part of treatment, accounting for 110 of 238 control-arm fractions (46.2%).
  • CBCT setup displacement and beam-on motion showed no significant differences in the intention-to-treat analysis. Surface-monitoring alerts occurred in 8.5% versus 6.7% of fractions, while repositioning was required in only 0.2% versus 0.4%.
  • No grade 2 or higher adverse events occurred. All events were grade 1; post-treatment somnolence occurred in 31.3% and nausea or vomiting in 25.0% of the sedation group, compared with one event of daytime sleepiness and one of nausea or vomiting in the WASPE group.

CLINICAL TAKEAWAY

A structured sleep-adjustment workflow may substantially reduce repeated sedation in toddlers who do not require mask immobilization, provided that CBCT, surface monitoring, trained caregivers, and rescue sedation remain available. The study demonstrates feasibility rather than equivalence: the control-arm crossover was extensive, head-and-neck treatment was excluded, and simulation still required sedation.

SOURCE

International Journal of Radiation Oncology, Biology, Physics