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Published on: September 11, 2011
Sleep Adjustment Strategy for Reducing Sedation Use in Pediatric Radiotherapy Under Surface Optical Monitoring: A
Pengyue Shi1, Wenheng Jiang1, Zheng Xu2
1Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Insights
A new sleep-adjustment protocol (WASPE) significantly reduced the need for sedation during radiation therapy (RT) for young children. This approach met feasibility goals without compromising treatment accuracy or safety.
Area of Science:
- Pediatric Oncology
- Radiation Therapy
- Anesthesiology
Background:
- Radiotherapy (RT) in young children often requires pharmacologic sedation for immobilization.
- Sedation poses procedural burdens and potential adverse effects.
- The study evaluated a structured sleep-adjustment protocol (WASPE) to decrease sedation use during pediatric RT.
Purpose of the Study:
- To assess the feasibility and safety of the Wake-Adaptation Sleep Protocol for Evening (WASPE) in reducing sedation during pediatric radiation therapy.
- To determine the per-fraction rate of RT completion without pharmacologic sedation in the WASPE arm.
- To evaluate secondary endpoints including setup accuracy, intrafraction motion, and safety.
Main Methods:
- A single-center, randomized phase II feasibility trial enrolled children aged 0-4 years requiring RT for solid tumors.
- Patients were randomized 2:1 to the WASPE protocol or standard chloral hydrate sedation.
- All patients received image-guided intensity-modulated RT with cone-beam CT (CBCT) and optical surface monitoring (OSMS).
Main Results:
- The WASPE protocol achieved a 96.4% sedation-free RT completion rate, meeting the feasibility criterion.
- No significant compromise in CBCT-based setup accuracy or OSMS-based motion was observed.
- No grade ≥2 treatment-related adverse events occurred in either the WASPE or sedation groups.
Conclusions:
- The WASPE protocol is a feasible and safe method for delivering sedation-free radiation therapy in children under 4 years old.
- This approach met feasibility benchmarks without compromising positional accuracy or short-term safety.
- WASPE offers a promising alternative to routine pharmacologic sedation in pediatric RT.
Purpose:
Young children undergoing radiation therapy (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 (watching videos, activities outdoors, stimulation to stay awake, playing with toys, and eating snacks [WASPE]) to reduce sedation use during pediatric RT under surface optical monitoring.
Methods And Materials:
Children aged 0 to 4 years requiring RT for solid tumors were enrolled in this single-center, pragmatic randomized phase 2 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 computed tomography setup verification and real-time optical surface monitoring. The primary endpoint was the per-fraction rate of RT completion without pharmacologic sedation in the WASPE arm, evaluated against a prespecified feasibility/noninferiority 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 cone beam computed tomography-based setup accuracy or optical surface monitoring-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.
Conclusions:
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.
