Oral Sedation With and Without Nitrous Oxide

Overview

Aims: The objective of the current study was to evaluate the effectiveness of oral midazolam-hydroxyzine with/without nitrous oxide. Design: This was a randomized split mouth, cross over and triple-blinded clinical study. Thirty uncooperative healthy children aged six to nine, whose needed dental treatments.

Full Title of Study: “Oral Sedation With/Without Nitrous Oxide in Pediatric Dental Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: January 6, 2019

Detailed Description

The purpose of this study was to compare the efficacy of combining oral midazolam-hydroxyzine with/without N2O/O2 in sedating uncooperative schoolchildren undergoing dental treatment. Thirty uncooperative healthy children aged six to nine were randomly selected to receive either one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 100% O2 (regimen A), or one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 50% N2O/O2 (regimen B) in a crossover design. Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment phase (injection, rubber dam RD, operating high-speed handpiece with touching the tooth without drilling) and the treatment phase (drilling, restoration).

Interventions

  • Drug: Midazolam-hydroxyzine with 100% O2
    • Patients received Oral Sedatives with 100% O2 ,Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.
  • Drug: Midazolam-hydroxyzine with 50% N2O/O2
    • Patients received Oral Sedatives with 50% nitrous ,Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.

Arms, Groups and Cohorts

  • Active Comparator: A: Midazolam-hydroxyzine with 100% O2
    • Midazolam-hydroxyzine with 100% O2 was administrated to 30 children. Drug: Oral Medication (midazolam 7.5 mg and hydroxyzine 10 mg) and Inhalation Gas 100% O2 Patients were randomly assigned to received one of two regimens (A,B) in across over design, Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.
  • Experimental: Midazolam-hydroxyzine with 50% N2O/ O2
    • children received Midazolam-hydroxyzine with 50% N2O/O2, one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 50% N2O/O2. Drug: Oral Medication and Inhalation Gas Patients were randomly assigned to received one of two regimens (A,B) in across over design, Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.

Clinical Trial Outcome Measures

Primary Measures

  • Behavior improvement on the modified Houpt behavioral rating scale
    • Time Frame: Behavior will assess at the end of the session (about 30-90 min) by evaluating the sessions ‘s videotapes using overall assessment (range from 1 to 4, higher values represent a better outcome) of the modified Houpt behavioral rating scale
    • Behavior assessment improvement related to the addition of N2O/O2 to the combination midazolam-hydroxyzine.
  • Behavior improvement on the modified Houpt behavioral rating scale
    • Time Frame: Behavior assess after 30 min of oral medications administered by evaluate the sessions’s videotapes using of Sleep,movement,Head/oral resistance,Cry,Verbal assessments(range1- 4,higher values is the better outcome)of modified Houpt behavioral scale
    • Behavior assessment improvement related to the addition of N2O/O2 to the combination midazolam-hydroxyzine.

Participating in This Clinical Trial

Criteria: Inclusion Criteria:

  • ASA Classification I.
  • minimum weight of 18 kg
  • uncooperative children scored 1 or 2 on Frankle Scale.
  • requiring nonemergency, bilateral mandibular dental treatments under local anesthesia.

Exclusion Criteria

  • known allergy to midazolam and/or hydroxyzine.
  • upper respiratory tract infection with nasal discharge.

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 9 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Tishreen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nabih Raslan, Principal investigator – Tishreen University
  • Overall Official(s)
    • Nabih Raslan, Dr, Study Chair, Tishreen University

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