RESUMO
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
Objective: To evaluate the association between the use of nonrecommended pharmacology (salbutamol and corticosteroids) per national bronchiolitis guidelines, either during the index visit or at discharge, and system utilization measures (frequency of return visits [RTED] and on paediatric emergency department [PED] length of stay [LOS]). Study Design: We conducted a retrospective case control study of 185 infants (≤12 months old) who presented to the PED between December 2014 and April 2017 and discharged home with a clinical diagnosis of bronchiolitis. Inclusion criteria included ≥ 1 viral prodromal symptom and ≥ 1 physical exam finding of respiratory distress. Cases were defined as infants who had ≥ 1 RTED within 7 days of their index visit and controls were matched for age and acuity but without RTED. Logistic regression analysis and multivariable linear regression were used to assess the odds of RTED and PED LOS associated with nonadherence to pharmaceutical recommendations per AAP and CPS bronchiolitis guidelines. Results: Use of nonrecommended pharmacology per national bronchiolitis guidelines was documented among 39% of the 185 study participants. Adjusting for acuity of index visit, age, severe tachypnea, oxygen desaturation, and dehydration, use of nonrecommended pharmacology was not associated with RTED (odds ratio [OR]: 0.98, 95% confidence interval [CI]: 0.47 to 2.03). Use of salbutamol and corticosteroids, however, were each independently associated with increased PED LOS (58.3 minutes [P=0.01] and 116.7 minutes [P<0.001], respectively). Conclusion: Nonadherence to the pharmaceutical recommendations of national bronchiolitis guidelines was not associated with RTED but salbutamol and corticosteroid use increased PED LOS.
