{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T12:54:17Z","timestamp":1740142457334,"version":"3.37.3"},"reference-count":23,"publisher":"FapUNIFESP (SciELO)","issue":"4","license":[{"start":{"date-parts":[[2019,7,1]],"date-time":"2019-07-01T00:00:00Z","timestamp":1561939200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2019,7,1]],"date-time":"2019-07-01T00:00:00Z","timestamp":1561939200000},"content-version":"am","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2019,7,1]],"date-time":"2019-07-01T00:00:00Z","timestamp":1561939200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Braz. Dent. J."],"abstract":"<jats:p>Abstract Crossover studies continue to be published in spite of warnings about their inherent risks in relation to behavioral outcomes. This study took the opportunity of access to secondary data analysis in order to demonstrate the impact of a crossover design on the outcomes of randomized clinical trials aimed at the behavior of children during dental treatment. We evaluated the effect of the sequence of sedative administration, the sedative and the participant\u2019s age on the behavior of children undergoing two sequential dental visits. Eighteen uncooperative healthy young children were equally randomly assigned to: (G1) 1.0 mg\/kg oral midazolam (first session) and oral placebo (second session); (G2) oral placebo (first) and 1.0 mg\/kg oral midazolam (second). One trained observer assessed children\u2019s behavior. Data were analyzed by three-way mixed ANOVA. Both midazolam [mean(SD); 71.7%(16.5)] and placebo [48.6%(33.1)] produced more struggling behavior when they were administered in the first session compared to the second one (p=0.001). For the placebo, children aged 2-3 years exhibited more struggling behavior [G1 54.9%(36.2); G2 80.5%(8.3)] than those aged 4-5 years (p=0.04). Also, the reduction of percentage of struggling behavior was higher in G1 for older children (76.2%) and in G2 for younger children (32.9%). There were significant interactions between drug and sequence of administration, and between drug and age. The results of our study confirm the conventional wisdom that crossover study design is inappropriate to evaluate children\u2019s behavior\/anxiety related-dental treatment under sedation and the results of crossover studies of dental sedation should be treated with extreme caution.<\/jats:p>","DOI":"10.1590\/0103-6440201902852","type":"journal-article","created":{"date-parts":[[2019,7,20]],"date-time":"2019-07-20T15:30:19Z","timestamp":1563636619000},"page":"404-409","source":"Crossref","is-referenced-by-count":6,"title":["Crossover Studies of Pediatric Dental Sedation are Inappropriate"],"prefix":"10.1590","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0065-9556","authenticated-orcid":false,"given":"Heloisa Sousa","family":"Gomes","sequence":"first","affiliation":[{"name":"Universidade Jos\u00e9 do Ros\u00e1rio Vellano,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0863-031X","authenticated-orcid":false,"given":"Anelise","family":"Daher","sequence":"additional","affiliation":[{"name":"Universidade Federal de Goi\u00e1s,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9370-9139","authenticated-orcid":false,"given":"Paulo Sucasas","family":"Costa","sequence":"additional","affiliation":[{"name":"Universidade Federal de Goi\u00e1s,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2117-5593","authenticated-orcid":false,"given":"Aline Carvalho","family":"Batista","sequence":"additional","affiliation":[{"name":"Universidade Federal de Goi\u00e1s,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7637-0049","authenticated-orcid":false,"given":"Luciane Rezende","family":"Costa","sequence":"additional","affiliation":[{"name":"Universidade Federal de Goi\u00e1s,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"530","published-online":{"date-parts":[[2019,7]]},"reference":[{"key":"ref1","doi-asserted-by":"crossref","first-page":"22","DOI":"10.4103\/ijdr.IJDR_181_16","article-title":"Evaluation of the influence of parental anxiety on children\u2019s behavior and understanding children\u2019s dental anxiety after sequential dental visits","volume":"28","author":"Shinde SD","year":"2017","journal-title":"Indian J Dent Res"},{"key":"ref2","doi-asserted-by":"crossref","DOI":"10.7717\/peerj.254","article-title":"Success rate of IR midazolam sedation in combination with C-CLAD in pediatric dental patients-a prospective observational study","volume":"2","author":"Ashkenazi M","year":"2014","journal-title":"Peer J"},{"key":"ref3","doi-asserted-by":"crossref","first-page":"334","DOI":"10.1590\/S0103-64402007000400012","article-title":"A randomized double-blinded trial of chloral hydrate with or without hydroxyzine versus placebo for pediatric dental sedation","volume":"18","author":"da Costa LR","year":"2007","journal-title":"Braz Dent J"},{"issue":"14","key":"ref4","article-title":"Randomized clinical trial on the efficacy of intranasal or oral ketamine-midazolam combinations compared to oral midazolam for outpatient pediatric sedation","volume":"11","author":"Sado-Filho J","year":"2019","journal-title":"PLoS One"},{"key":"ref5","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0180248","article-title":"What is the level of evidence for the amnestic effects of sedatives in pediatric patients? 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