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. 2015 Jun;25(3):e494.
doi: 10.5812/ijp.25(3)2015.494. Epub 2015 Jun 27.

Efficacy and Safety of Orally Administered Intravenous Midazolam Versus a Commercially Prepared Syrup

Katayoun Salem  1 , Hossein Khoshrang  2 , Maryam Kousha  3 , Mahboobeh Hoseini  1 , Marzieh Ranjbar  1 , Shadi Baniasadi  4 , Jamshid Salamzadeh  5
Affiliations

Efficacy and Safety of Orally Administered Intravenous Midazolam Versus a Commercially Prepared Syrup

Katayoun Salem et al. Iran J Pediatr. 2015 Jun.

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.

Objectives: 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.

Patients and 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.

Keywords: Child; Clinical Trial; Oral Midazolam; Sedation; Uncooperative Patient.

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Figures

Figure 1.
Figure 1.. Consort Flow Diagram of Study Groups
Figure 2.
Figure 2.. Mean (SD) Values of Heart Rate Among Syrup (A) Versus “Orally Administered IV Midazolam (B)
Independent t-test, P > 0.05.
Figure 3.
Figure 3.. Mean (SD) Values of Systolic and Diastolic Blood Pressure in Syrup (A) Versus “Orally Administered IV Midazolam (B)” Groups
Independent t-test P > 0.05.
Figure 4.
Figure 4.. Mean (SD) Values of Respiratory Rate in Syrup (A) Versus “Orally Administered IV Midazolam (B)” Groups
Independent t-test, P > 0.05.
Figure 5.
Figure 5.. Distribution of SDQ-Total and Subdomains of SDQ in Study Patients
See this image and copyright information in PMC

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References

    1. Raadal M, Lundeberg S, Haukali G. Pain, pain control and sedation. In: Koch G, Poulsen S, editors. Pediatric Dentistry, A Clinical Approach. 2 ed. Singapore: Blackwell; 2009. p. 54.
    1. Wilson S, Ganzberg L. Pediatric Dentistry, Infancy through Adolescence. 5 ed. China: Elsevier; 2013. Pain Reaction Control: Sedation. p. 98.
    1. McDonald R, Avery D. Dentistry for the child and adolescent. 9 ed. ,China: Mosby-Elsivier; 2013.
    1. Malamed S. Oral Sedation. 5 ed. California: Mosbey Elsevier; 2010. - DOI
    1. Reed MD, Rodarte A, Blumer JL, Khoo KC, Akbari B, Pou S, et al. The single-dose pharmacokinetics of midazolam and its primary metabolite in pediatric patients after oral and intravenous administration. J Clin Pharmacol. 2001;41(12):1359–69. - PubMed

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