Oral Sedation With and Without Nitrous Oxide

January 5, 2019 updated by: Nabih Raslan, Tishreen University

Oral Sedation With/Without Nitrous Oxide in Pediatric Dental Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 9 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tishreen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 17, 2018

Primary Completion (ACTUAL)

January 6, 2019

Study Completion (ACTUAL)

January 6, 2019

Study Registration Dates

First Submitted

October 26, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (ACTUAL)

November 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2019

Last Update Submitted That Met QC Criteria

January 5, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tishreen-sedation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

up to date, there is no decision about IPD sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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