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Trial registered on ANZCTR
Registration number
ACTRN12624000945527
Ethics application status
Approved
Date submitted
13/06/2024
Date registered
5/08/2024
Date last updated
5/08/2024
Date data sharing statement initially provided
5/08/2024
Date results provided
5/08/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluation of buccal midazolam in comparison with intranasal midazolam sedation in uncooperative children during dental treatment.
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Scientific title
Evaluation of the efficacy of buccal midazolam in comparison with intranasal midazolam sedation in uncooperative children during dental treatment.
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Secondary ID [1]
312338
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
dental treatment
334105
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Condition category
Condition code
Oral and Gastrointestinal
330780
330780
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Anaesthesiology
330988
330988
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0
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Other anaesthesiology
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Brief name: midazolam sedation.
The children received undiluted midazolam (5mg/ml) in a dose of 0.3 mg/kg. In group A, intranasal midazolam was sprayed into both nostrils using a mucosal atomizing device (MAD) (MAD 300, Teleflex medical Inc., USA).
the intervention is applied relative to dental treatment: before dental treatment, the level of sedation was considered appropriate for treatment when the patient seemed relaxed or when he showed delaying in speech and in response for commands.
the intervention drug administered by the dentist,
strategies used to monitor adherence : direct observation.
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Intervention code [1]
328825
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Treatment: Drugs
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Comparator / control treatment
In group B, (comparator) buccal midazolam. In group B, midazolam was sprayed in the buccal sulcus using the mucosal atomizing device after applying lips retractor, and drying the mucosal membrane.
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Control group
Active
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Outcomes
Primary outcome [1]
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the percentage of effectiveness in the management of uncooperative children during dental treatment.
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Assessment method [1]
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The Houpt scale was used to assess the behavioral response during procedure.
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Timepoint [1]
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the variables were evaluated in two phases, the first phase is at the moment of local anesthesia, the second phase is after 15 minutes from anesthesia.
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Nil
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Timepoint [1]
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Nil
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Eligibility
Key inclusion criteria
The patient is classified as The American Society of Anesthesiologists (ASA) physical status classification system (I and II), patient’s behavior is within the second degree (negative) of the Frankle scale, and the patient needs a dental treatment which includes pulpotomy for a lower molar.
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Minimum age
3
Years
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Maximum age
6
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
A patient who refused to participate in the study, the known hypersensitivity to midazolam, upper respiratory tract infection or tonsillar hypertrophy, children with aggressive behavior or high resistance for treatment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
12/05/2021
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Date of last participant enrolment
Anticipated
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Actual
30/06/2022
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Date of last data collection
Anticipated
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Actual
30/06/2022
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Sample size
Target
40
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Accrual to date
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Final
40
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Recruitment outside Australia
Country [1]
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Syrian Arab Republic
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State/province [1]
26377
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Damascus
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Address [1]
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Country [1]
316735
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Syrian Arab Republic
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Primary sponsor type
University
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Name
University of Damascus
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Address
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Country
Syrian Arab Republic
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
318945
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Country [1]
318945
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Ethics Committee of Damascus University, Damascus, Syria (IRB number: UDDS-3232-07092020/SRC-631).
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Ethics committee address [1]
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info@damascusuniversity.edu.sy
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Ethics committee country [1]
315509
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Syrian Arab Republic
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Date submitted for ethics approval [1]
315509
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05/11/2020
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Approval date [1]
315509
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09/11/2020
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Ethics approval number [1]
315509
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Summary
Brief summary
Behavioral management techniques are not always sufficient, and then it is necessary to use pharmacological management methods. Intranasal midazolam sedation is effective in the management of children during dental treatment, buccal midazolam sedation is more tolerated and acceptable by children than intranasal way. To compare the effectiveness of buccal midazolam sedation with intranasal midazolam in uncooperative children during dental treatment, a sample consisted of 40 children aged 3 to 6 years who were divided randomly into two groups: Group A intranasal midazolam and Group B buccal midazolam. The onset time of action and recovery time from sedation were compared between the two groups, the efficacy of sedation was evaluated by Houpt behavior scale. There were no statistically significant differences in the onset time of action and recovery time from sedation. There were no statically significant differences between the two groups in sleep, crying, and movement categories, or in the overall Houpt scale, there were statistically significant differences in the sleep variable between the two studied phases in the intranasal group (p=0.014), and in the movement variable in the buccal group (p=0.039). Conclusion: both intranasal and buccal midazolam sedation were effective in the management of uncooperative children during dental treatment, in a percent of 85% in the buccal group and 80% in the intranasal group.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Doaa Arnaout
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Address
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Damascus university, PO Box 30621 Almazeeh Street, Damascus, Syria.
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Country
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Syrian Arab Republic
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Phone
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+963938219374
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Doaa Arnaout
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Address
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Damascus university, PO Box 30621 Almazeeh Street, Damascus, Syria.
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Country
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Syrian Arab Republic
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Phone
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+963938219374
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Doaa Arnaout
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Address
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Damascus university, PO Box 30621 Almazeeh Street, Damascus, Syria.
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Country
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Syrian Arab Republic
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Phone
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+963938219374
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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