100 External Cold and Vibration for Pain Management of Children Undergoing Needle-Related Procedures in the Emergency Department: A Randomized Controlled Non-Inferiority Trial
Bibliographic record
Abstract
Needle-related procedures are considered as the most important source of pain and distress in children in hospital settings. Time constraints, heavy workload, busy and noisy environment represents barriers to the use of available interventions for pain management during needle-related procedures. Therefore, the use of a rapid, easy-to-use intervention could improve procedural pain management practices. To determine if a device combining cold and vibration (Buzzy) is non-inferior (no worse) to a topical anesthetic (Maxilene) for pain management in children undergoing needle-related procedures in the Emergency Department (ED). This study was a randomized, controlled, non-inferiority trial. We enrolled children aged between 4–17 years presenting to the ED and requiring a needle-related procedure. Participants were randomly assigned to the Buzzy or Maxilene group. Primary outcome was the mean difference in pain intensity during the procedure, as measured with the CAS (0–10). Secondary outcomes were procedural distress, success of the procedure at first-attempt and satisfaction of parents. A total of 352 participants were enrolled and 346 were randomized (Buzzy=172; Maxilene=174). Mean difference in procedural pain scores between groups was 0.64 (95%CI -0.1 to 1.3), showing that the Buzzy device was not non-inferior to Maxilene according to a non-inferiority margin of 0.70. No significant differences were observed for procedural distress (p=.370) and success of the procedure at first attempt (p=.602). Parents of both groups were very satisfied with both interventions (Buzzy=7.8 ±2.66; Maxilene=8.1 ±2.4), but there was no significant difference between groups (p=.236). Non-inferiority of the Buzzy device over a topical anesthetic was not demonstrated for pain management of children during a needle-related procedure in the ED. However, considering that topical anesthetics are underused in the ED setting and require time, the Buzzy device seems to be a promising alternative as it is a rapid, low-cost, easy-to-use and reusable intervention.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".