Reducing distress for children during invasive procedures: randomized clinical trial of effectiveness of the PediSedate<sup>®</sup>
Bibliographic record
Abstract
BACKGROUND: Procedural pain control remains problematic for young children, especially during anxiety-causing procedures for which children should not be deeply sedated. The PediSedate was designed to address this problem by delivering nitrous oxide in oxygen through a simple nosepiece, combined with an interactive video component, so that children can use attention and distraction with drug delivery. OBJECTIVES: We conducted a randomized clinical trial to evaluate the effectiveness of the PediSedate for reducing children's behavioral distress in comparison with standard care in the emergency department. Secondary objectives were to assess children's acceptance, cooperation, and pain. METHODS: Thirty-six children, aged 3-9 years old, who required invasive procedures associated with high levels of anxiety and low levels of pain such as sutures, IVs, and lumbar punctures were randomized to receive either the standard care or the PediSedate. The primary outcome was children's distress (observational scale of behavioral distress) that was monitored before and during the procedure. RESULTS: Children randomized to the PediSedate group had significantly less distress during invasive procedures (mean = 1.8, sd = 3.2) than children receiving standard care (mean = 9.3, SD = 5.6; anova, P < 0.0001). Also, children in the PediSedate group were more cooperative [chi(2)(1) = 22.05, P < 0.0001] and fewer children reported pain [chi(2)(1) = 14.45, P < 0.001]. CONCLUSIONS: Previous studies have demonstrated the effectiveness of nitrous oxide sedation alone for minimizing pain and distress during invasive procedures. We have found that delivering nitrous oxide sedation via a system combined with an interactive video component is also effective. Further studies should determine which factors are dominant and determine the specific failure rate for this delivery system in comparison with other systems.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.007 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".