RESUMEN
OBJECTIVE: Intranasal (IN) midazolam is a commonly prescribed medication for pediatric sedation and anxiolysis. One of its most frequently encountered adverse effects is discomfort with administration. While it has been proposed that premedicating with lidocaine reduces this undesirable consequence, this combination has not been thoroughly researched. The objective of our study was to assess whether topical lidocaine lessens the discomfort associated with IN midazolam administration. METHODS: This was a double-blind, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department. Children 6-12 years of age who were receiving IN midazolam for procedural sedation received either 4% lidocaine or 0.9% saline (placebo) via mucosal atomizer. Subjects were subsequently given IN midazolam in a similar fashion and then rated their discomfort using the Wong-Baker FACES Pain Rating Scale (WBS). The primary endpoint of WBS score was analyzed with a two-tailed Mann-Whitney U-test, with p < 0.05 considered statistically significant. RESULTS: Seventy-seven patients were enrolled over a consecutive 8-month period. One child was excluded from analysis due to a discrepancy in recording the drug identification number. Study groups were similar in regard to demographic information and indication for sedation. Subjects who received IN lidocaine reported less discomfort with IN midazolam administration (median WBS = 3, interquartile range [IQR] = 0-6) than those who received placebo (median WBS = 8, IQR = 2-9; p = 0.006). CONCLUSIONS: Premedication with topical lidocaine reduces the discomfort associated with administration of IN midazolam (ClinicalTrials.gov, NCT02396537).
Asunto(s)
Anestésicos Locales/administración & dosificación , Hipnóticos y Sedantes/administración & dosificación , Lidocaína/administración & dosificación , Midazolam/administración & dosificación , Premedicación/métodos , Administración Intranasal , Administración Tópica , Niño , Método Doble Ciego , Femenino , Humanos , Masculino , Midazolam/efectos adversos , Dimensión del DolorRESUMEN
OBJECTIVES: The purpose of this study was to evaluate the difference between education via written materials alone and written materials enhanced with hands-on simulation. METHODS: A simulation case, educational module, and assessment regarding torsades de pointes (TdP) in an adolescent patient were designed. The written educational module was given to all study participants. A total of 92 third-year pharmacy students and 26 pharmacists participated in the study. RESULTS: When approximately half of the participants had been to simulation, an anonymous assessment was given. Responses from those who had been to simulation and those who had not, and whether they had read, skimmed or not read the educational material were compared. A non-paired Student t-test compared the percentage correct and responses of individual questions between groups. Mean participant scores of those who went to simulation (70% ± 16%) were statistically significantly higher than mean scores of those who had not attended simulation (54% ± 21%; p<0.0001). Furthermore, those who attended simulation and read the module (72% ± 3%), skimmed (68% ± 13%), or did not read the module (66% ± 16%) had higher scores than those who did not attend simulation and read the module (62% ± 26%), skimmed the module (54 ± 17%) or did not read the module (51% ± 20%). CONCLUSIONS: Hands-on simulation significantly improved assessment scores. Overall, reading the educational module and participating in simulation yielded the best scores. Participants who attended the simulation and did not read the module had higher average scores than participants who read the educational module and did not go to simulation.