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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.
RESUMO
OBJECTIVES: To evaluate the psychometric properties of HEARTSMAP, an emergency psychosocial assessment and management tool, and its impact on patient care and flow measures. METHODS: We conducted the study in two phases: first validating the tool using extracted information from a retrospective cohort, then evaluating implementation on a prospective cohort of youth presenting with mental health complaints to a tertiary Pediatric Emergency Department (PED). In phase 1, six PED clinicians applied HEARTSMAP to extracted narratives and we calculated inter-rater agreement for referral recommendations using Cohen's Kappa and the sensitivity and specificity for identifying youth requiring psychiatric consultation and hospitalization. In phase 2, PED clinicians prospectively used HEARTSMAP and we assessed the impact of the tool's implementation on patient-related outcomes and Emergency department (ED) flow measures. RESULTS: We found substantial agreement (κ=0.7) for cases requiring emergent psychiatric consultation and moderate agreement for cases requiring community urgent and non-urgent follow-up (κ=0.4 each). The sensitivity was 76% (95%CI: 63%, 90%) and specificity was 65% (95%CI: 55%, 71%) using retrospective cases. During pilot implementation, 62 patients received HEARTSMAP assessments: 46 (74%) of HEARTSMAP assessments triggered a recommendation for ED psychiatry assessment, 39 (63%) were evaluated by psychiatry and 13 (21%) were admitted. At follow-up, all patients with HEARTSMAP's triggered recommendations had accessed community resources. For those hospitalized for further psychiatric care at their index or return visit within 30 days, 100% were initially identified by HEARTSMAP at the index visit as requiring ED psychiatric consultation. CONCLUSIONS: HEARTSMAP has strong reliability, and when applied prospectively is a safe and effective management tool.
