Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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 information initially 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.
Scientific title
Evaluation of the efficacy of buccal midazolam in comparison with intranasal midazolam sedation in uncooperative children during dental treatment.
Secondary ID [1] 312338 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental treatment 334105 0
Condition category
Condition code
Oral and Gastrointestinal 330780 330780 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 330988 330988 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328825 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 338538 0
the percentage of effectiveness in the management of uncooperative children during dental treatment.
Timepoint [1] 338538 0
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.
Secondary outcome [1] 436342 0
Nil
Timepoint [1] 436342 0
Nil

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.
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/05/2021
Date of last participant enrolment
Anticipated
Actual
30/06/2022
Date of last data collection
Anticipated
Actual
30/06/2022
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 26377 0
Syrian Arab Republic
State/province [1] 26377 0

Funding & Sponsors
Funding source category [1] 316735 0
University
Name [1] 316735 0
University of Damascus
Country [1] 316735 0
Syrian Arab Republic
Primary sponsor type
University
Name
University of Damascus
Address
Country
Syrian Arab Republic
Secondary sponsor category [1] 318945 0
None
Name [1] 318945 0
Address [1] 318945 0
Country [1] 318945 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315509 0
Ethics Committee of Damascus University, Damascus, Syria (IRB number: UDDS-3232-07092020/SRC-631).
Ethics committee address [1] 315509 0
[email protected]
Ethics committee country [1] 315509 0
Syrian Arab Republic
Date submitted for ethics approval [1] 315509 0
05/11/2020
Approval date [1] 315509 0
09/11/2020
Ethics approval number [1] 315509 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134922 0
Dr Doaa Arnaout
Address 134922 0
Damascus university, PO Box 30621 Almazeeh Street, Damascus, Syria.
Country 134922 0
Syrian Arab Republic
Phone 134922 0
+963938219374
Fax 134922 0
Email 134922 0
[email protected]
Contact person for public queries
Name 134923 0
Doaa Arnaout
Address 134923 0
Damascus university, PO Box 30621 Almazeeh Street, Damascus, Syria.
Country 134923 0
Syrian Arab Republic
Phone 134923 0
+963938219374
Fax 134923 0
Email 134923 0
[email protected]
Contact person for scientific queries
Name 134924 0
Doaa Arnaout
Address 134924 0
Damascus university, PO Box 30621 Almazeeh Street, Damascus, Syria.
Country 134924 0
Syrian Arab Republic
Phone 134924 0
+963938219374
Fax 134924 0
Email 134924 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.