title: A preliminary randomised double-blind placebo-controlled clinical trial of hydroxyzine for treating sleep bruxism in children.
abstract: This is a randomised placebo-controlled clinical trial investigating the efficacy of hydroxyzine for treating parent-reported sleep bruxism in children. Participants of this trial were 30 patients randomly allocated to one of the two groups in a ratio of 1:2. One group received hydroxyzine and the other group received placebo. The outcome measures were Visual Analogue Scale test and Clinical Global Severity scale. Assessments occurred at baseline and at the end of week 4. The side effects of drugs were assessed using a checklist. The number of children in the hydroxyzine and placebo groups was 21 and 9, respectively. The mean age of children in the hydroxyzine and placebo groups was 8·4(s.d. = 3·3) and 6·5(s.d. = 1·5) years, respectively. Hydroxyzine more than placebo decreased bruxism score (3·8 versus 2·2). No serious adverse effect was reported. Current evidence support that hydroxyzine is effective and well tolerated for treating bruxism in children.
authors.affiliation: Research Center for Psychiatry and Behavioral Sciences, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. ghanizad@sina.tums.ac.ir
authors.forename: A
authors.initials: A
authors.lastname: Ghanizadeh
authors.forename: S
authors.initials: S
authors.lastname: Zare
mesh_terms: D000374:Aggression / Q000187:drug effects; D001066:Appetite / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D003221:Confusion / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D006261:Headache / Q000139:chemically induced; D006634:Histamine H1 Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006919:Hydroxyzine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D020186:Sleep Bruxism / Q000188:drug therapy*; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D006634:Histamine H1 Antagonists; D006919:Hydroxyzine