A randomized controlled pilot study of intranasal lidocaine in acute management of paediatric migraine and migraine-like headache
Bibliographic record
Abstract
Objectives: This study was aimed to determine the sample size required to conduct an efficacy randomized controlled trial (RCT) to evaluate superiority of intranasal (IN) lidocaine to placebo as an analgesic option for children presenting to the paediatric emergency department (PED) with migraine or posttraumatic headache with migraine features and to evaluate study protocol feasibility. Study Design: This study is a double-blind RCT of children aged 7 to 16 years at a single-centre PED. Thirty-two participants were randomized to receive either IN 2% lidocaine or 0.9% sodium chloride. The primary outcome measure was the proportion of subjects with a Verbal Numeric Rating Scale pain score of <4 at 30 and 60 minutes post-IN therapy. Primary outcome data were analyzed using a test of differences between proportions. Secondary objectives included assessing the feasibility of our study protocol by evaluating recruitment rates, adverse drug events, and PED length of stay (LOS). Results: Six of 17 participants in the lidocaine group and 2 of 15 in the placebo group were treated successfully. Using these proportions with 95% confidence intervals and 80% power, the sample size required to find a significant difference between proportions would be 67 participants per arm. Our enrolment rate was 55% and there were no serious adverse drug events. The median PED LOS was similar between groups. Conclusion: We determined the sample size required to conduct a definitive RCT to evaluate the superiority of IN lidocaine to placebo and found the study protocol is feasible but identified important considerations in PED migraine trial design.
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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 | 0.014 | 0.018 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 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".