Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Patients

October 24, 2020 updated by: Nourhan M.Aly

Efficacy of Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Dental Patients

Purpose of this study was to assess the efficacy of aerosolized midazolam, introduced through buccal versus intranasal mucosa in managing uncooperative children undergoing dental treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Thirty six children fulfilling the requirements of having a dental condition that needed treatment in two dental settings, not exceeding thirty minutes each. They were randomly assigned to one of two groups, according to the treatment offered at the first visit. At the first visit, either buccal or intranasal aerosolized midazolam was administered. At the second visit the alternate route was implemented in a cross-over design with a one week washout period. Vital signs were recorded at baseline and at 5 minutes interval throughout the treatment session.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

  • Egypt
      • Alexandria, Egypt, 21512
        • Faculty of dentistry, Alexandria university

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Negative and definitely negative behavior according Frankl's scale.
  • ASA Group I (normal healthy patient without systemic disease) and II (patient with mild systemic disease) with no medical contraindication which rules out the use of midazolam.
  • Children with at least two carious lesions requiring dental intervention in two settings of not more than 30 minute each.

Exclusion Criteria:

  • Children with multiple carious lesions who require treatment under general anesthesia.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Buccal midazolam
Drug: Buccal midazolam
The drug was sprayed in the buccal vestibule across the area between the primary first and second molars in all four quadrants to maximize the absorption through wide area of the buccal mucosa.
Active Comparator: Intranasal midazolam
Drug: Intranasal midazolam
Half of the dose was sprayed in the right nostril and the other half in the left nostril to double the absorptive surface area by short and quick puffs.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptance of drug administration
Time Frame: during the sedation procedure
Assessed by a 3 point Likert scale as follows: (1) the child accepted the drug readily. 2 (fair) the child accepted the drug with some resistance. 3 (poor) the child accepted the drug with great resistance. 4 (refused) the child refused but drug administration was possible after persuasion.
during the sedation procedure
Sleep score
Time Frame: after 5 minutes

This will be assessed using modified Houpt scale for behavior rating:

  1. Awake, alert.
  2. Drowsy, disoriented.
  3. Intermittently asleep.
  4. Sound asleep.
after 5 minutes
Crying score
Time Frame: after 5 minutes

This will be assessed using modified Houpt scale for behavior rating:

  1. Hysterical, demands attention.
  2. Continuous, making treatment difficult.
  3. Intermittent, mild, does not interfere with treatment.
  4. No crying present.
after 5 minutes
Head/oral resistance score
Time Frame: after 5 minutes

This will be assessed using modified Houpt scale for behavior rating:

  1. Turns head, refuses to open mouth.
  2. Mouth closing, must request to open.
  3. Chocking, gagging, spitting.
  4. No head/oral resistance present.
after 5 minutes
Overall behavior
Time Frame: immediately after completion of the dental treatment procedures

This will be assessed using modified Houpt scale for behavior rating:

  1. Aborted, no treatment performed.
  2. Very poor, treatment interrupted, partial treatment completed.
  3. Fair, difficult, all treatment completed.
  4. Good, some limited crying or movement.
  5. Excellent, no crying or movement.
immediately after completion of the dental treatment procedures

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nourhan M.Aly

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alexandria University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yousr N Mowafy, M.Sc, Faculty of Dentistry, Alexandria University, Egypt
  • Study Director: Nadia A Wahba, PhD, Faculty of Dentistry, Alexandria University, Egypt
  • Study Chair: Tamer M Ghoneim, PhD, Faculty of Medicine, Alexandria University, Egypt
  • Study Chair: Ghada M Mahmoud, PhD, Faculty of Dentistry, University of Modern Sciences and Arts, Egypt.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Buccal vs intranasal midazolam

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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