Sleep Adjustment Strategy for Reducing Sedation Use in Pediatric Radiotherapy Under Surface Optical Monitoring: A Pragmatic Randomized Feasibility Trial.
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INTRODUCTION: Young children undergoing radiotherapy (RT) frequently require pharmacologic sedation to achieve adequate immobilization, which is associated with procedural burden and potential adverse effects. We evaluated the feasibility and safety of a structured sleep-adjustment protocol (WASPE) for reducing sedation use during pediatric RT under surface optical monitoring. MATERIALS AND METHODS: Children aged 0-4 years requiring RT for solid tumors were enrolled in this single-center, pragmatic randomized phase II feasibility trial (ClinicalTrials.gov NCT06443632) and randomized 2:1 to WASPE or standard chloral-hydrate sedation. All patients received image-guided intensity-modulated RT with cone-beam CT (CBCT) setup verification and real-time optical surface monitoring (OSMS). The primary endpoint was the per-fraction rate of RT completion without pharmacologic sedation in the WASPE arm, evaluated against a prespecified feasibility/non-inferiority threshold. Secondary endpoints included interfraction setup accuracy, intrafraction motion, exploratory immune and endocrine biomarkers, and treatment-related adverse events. RESULTS: Forty-eight patients were enrolled, with 32 assigned to WASPE and 16 to sedation. In the WASPE arm, 448 RT fractions were delivered, of which 432 (96.4%) were completed without pharmacologic sedation. The estimated marginal sedation-free completion rate was 96.2% (95% CI, 93.3%-97.9%), meeting the prespecified feasibility criterion. In the sedation arm, 7 children partially crossed over to WASPE, accounting for 110 of 238 control-arm fractions (46.2%). No clear signal of worsened CBCT-based setup accuracy or OSMS-based beam-on motion was observed with WASPE, although these secondary comparisons should be interpreted cautiously given crossover between randomized strategies. No significant group-by-time differences were observed in serum immunoglobulin or growth hormone levels. No grade ≥2 treatment-related adverse events occurred in either group. CONCLUSION: WASPE enabled a high rate of sedation-free RT delivery in children younger than 4 years and met the prespecified feasibility benchmark, without an obvious signal of compromised positional adequacy or serious short-term safety concern in this feasibility trial.