NCT03728894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

November 17, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2019

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

October 26, 2018

Last Update Submit

January 5, 2019

Conditions

Behavior, Child

Keywords

Midazolamhydroxyzineoxygenbehaviorchildtooth

Outcome Measures

Primary Outcomes (2)

  • Behavior improvement on the modified Houpt behavioral rating scale

    Behavior assessment improvement related to the addition of N2O/O2 to the combination midazolam-hydroxyzine.

    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 improvement on the modified Houpt behavioral rating scale

    Behavior assessment improvement related to the addition of N2O/O2 to the combination midazolam-hydroxyzine.

    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

Study Arms (2)

A: Midazolam-hydroxyzine with 100% O2

ACTIVE COMPARATOR

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

Midazolam-hydroxyzine with 50% N2O/ O2

EXPERIMENTAL

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

Interventions

Midazolam-hydroxyzine with 100% O2DRUG

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.

Also known as: A
A: Midazolam-hydroxyzine with 100% O2
Midazolam-hydroxyzine with 50% N2O/O2DRUG

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.

Also known as: B
Midazolam-hydroxyzine with 50% N2O/ O2

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tishreen University

Latakia, Syria

Location

MeSH Terms

Conditions

Child BehaviorBehavior

Study Officials

  • Nabih Raslan, Dr

    Tishreen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: blinded, randomized controlled trial, comparing two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 26, 2018

First Posted

November 2, 2018

Study Start

November 17, 2018

Primary Completion

January 6, 2019

Study Completion

January 6, 2019

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations

SY(1)