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Oral Sedation With and Without Nitrous Oxide

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ClinicalTrials.gov Identifier: NCT03728894
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Nabih Raslan, Tishreen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Behavior, Child Drug: Midazolam-hydroxyzine with 100% O2 Drug: Midazolam-hydroxyzine with 50% N2O/O2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: blinded, randomized controlled trial, comparing two groups.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Triple (Participant, Care Provider, Outcomes Assessor) Each of the children/parents, the dentist and the outcomes assessors were blinded. To ensure the blindness of the dentist, the inhalation sedation machine was placed in a way that he could not see the flow rate panel or the type of the administered gases.
Primary Purpose: Treatment
Official Title: Oral Sedation With/Without Nitrous Oxide in Pediatric Dental Patients
Actual Study Start Date : November 17, 2018
Actual Primary Completion Date : January 6, 2019
Actual Study Completion Date : January 6, 2019


Arm Intervention/treatment
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.
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.
Other Name: A

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.
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.
Other Name: B




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728894


Locations
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Syrian Arab Republic
Tishreen University
Latakia, Syrian Arab Republic
Sponsors and Collaborators
Tishreen University
Investigators
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Study Chair: Nabih Raslan, Dr Tishreen University
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Responsible Party: Nabih Raslan, Principal investigator, Tishreen University
ClinicalTrials.gov Identifier: NCT03728894    
Other Study ID Numbers: Tishreen-sedation
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: up to date, there is no decision about IPD sharing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nabih Raslan, Tishreen University:
Midazolam
hydroxyzine
oxygen
behavior
child
tooth
Additional relevant MeSH terms:
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Midazolam
Hydroxyzine
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents