title: Efficacy and Safety of Orally Administered Intravenous Midazolam Versus a Commercially Prepared Syrup.
abstract: BACKGROUND
  Among different categories of sedative agents, benzodiazepines have been prescribed for more than three decades to patients of all ages. The effective and predictable sedative and amnestic effects of benzodiazepines support their use in pediatric patients. Midazolam is one of the most extensively used benzodiazepines in this age group. Oral form of drug is the best accepted route of administration in children.
  
  
  OBJECTIVE
  The purpose of this study was to compare the efficacy and safety of a commercially midazolam syrup versus orally administered IV midazolam in uncooperative dental patients. Second objective was to determine whether differences concerning sedation success can be explained by child's behavioral problems and dental fear.
  
  
  METHODS
  Eighty eight uncooperative dental patients (Frankl Scales 1,2) aged 3 to 6 years, and ASA I participated in this double blind, parallel randomized, controlled clinical trial. Midazolam was administered in a dose of 0.5 mg/kg for children under the age 5 and 0.2 mg/kg in patients over 5 years of age. Physiologic parameters including heart rate, respiratory rate, oxygen saturation and blood pressure were recorded. Behavior assessment was conducted throughout the course of treatment using Houpt Sedation Rating Scale and at critical moments of treatment (injection and cavity preparation) by North Carolina Scale. Dental fear and behavioral problems were evaluated using Child Fear Schedule Survey-Dental Subscale (CFSS-DS), and Strength and Difficulties Questionnaire (SDQ). Independent t-test, Chi-Square, and Pearson correlation were used for statistical analysis.
  
  
  RESULTS
  Acceptable overall sedation ratings were observed in 90% and 86% of syrup and IV/Oral group respectively; Chi-Square P = 0.5. Other domains of Houpt Scale including: sleep, crying and movement were also not significantly different between groups. Physiological parameters remained in normal limits during study without significant difference between groups.
  
  
  CONCLUSIONS
  "Orally administered IV midazolam" preparation can be used as an alternative for commercially midazolam syrup.
authors.affiliation: Department of Pediatric Dentistry and Dentistry Hospital, Guilan Dental School, Rasht, IR Iran.
authors.forename: Katayoun
authors.initials: K
authors.lastname: Salem
authors.affiliation: Department of Anesthesiology, Guilan University of Medical Sciences, Rasht, IR Iran.
authors.forename: Hossein
authors.initials: H
authors.lastname: Khoshrang
authors.affiliation: Department of Child Psychiatry, Guilan University of Medical Sciences, Rasht, IR Iran.
authors.forename: Maryam
authors.initials: M
authors.lastname: Kousha
authors.affiliation: Department of Pediatric Dentistry and Dentistry Hospital, Guilan Dental School, Rasht, IR Iran.
authors.forename: Mahboobeh
authors.initials: M
authors.lastname: Hoseini
authors.affiliation: Department of Pediatric Dentistry and Dentistry Hospital, Guilan Dental School, Rasht, IR Iran.
authors.forename: Marzieh
authors.initials: M
authors.lastname: Ranjbar
authors.affiliation: Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, IR Iran.
authors.forename: Shadi
authors.initials: S
authors.lastname: Baniasadi
authors.affiliation: Deparment of Clinical Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, IR Iran.
authors.forename: Jamshid
authors.initials: J
authors.lastname: Salamzadeh
keywords: Child; Clinical Trial; Oral Midazolam; Sedation; Uncooperative Patient