Dental SedationPhase 2/3NCT05883150
Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment
A Phase 2/3 study testing Nebulized Midazolam and Intranasal Midazolam in people with Dental Sedation, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
The aim of the current study is to compare the effect of intranasal versus nebulized route of administration of midazolam as moderate sedative agents in preschoolers undergoing dental treatment. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Dental Sedation
- What is being tested?
- Nebulized Midazolam and Intranasal Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2022to 30 Aug 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Frankl scale score 2.
- ASA I or II physical status.
- Dental intervention under local anesthesia not requiring more than 30 minutes.
- No previous dental experience.
- Parent/guardian's written consent.
Who cannot join
- Dental treatment indicated under general anesthesia.
- Presence of facial or nasal deformities.
- History of neurological or cognitive alterations.
- Mouth breathers
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental Medicine, Kafrelsheikh University, Kafrelsheikh, Egypt
Kafr ash Shaykh
About this study
Official title: Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment: A Randomized Clinical Trial
The aim of the current study is to compare the effect of intranasal versus nebulized route of administration of midazolam as moderate sedative agents in preschoolers undergoing dental treatment.
- Conditions
- Dental Sedation
- Being tested
- Nebulized Midazolam, Intranasal Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized MidazolamDrug
All the drug solutions will be freshly prepared on the day of sedation session. Depending on the dosage calculated from the weight of each child The sedative drug, the dosage will be diluted with an equal volume by adding distilled water.
The child will be seated in an upright position on the dental chair. Before placing the mask of the nebulizer, the child will be coached into proper breathing pattern
Intranasal MidazolamDrug
All the drug solutions will be freshly prepared on the day of sedation session. Depending on the dosage calculated from the weight of each child, For children who will receive midazolam using the atomization device attached to a three-ml syringe, the child sitting reclined in knee-to-knee position. Half of the dose will be sprayed in the right nostril and the other half will be sprayed in the left nostril to double the absorptive surface area by short and quick puffs
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Midazolam | Experimental | Not described Receives: Drug: Nebulized Midazolam |
| Intranasal Midazolam | Active comparator | Not described Receives: Drug: Intranasal Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior rating
This will be recorded using the Modified Houpt scale for behavior rating; Sleep, head/oral resistance, crying and overall behavior will be scored on a 6-point scale ranging from 1-6 with higher scores indicating better behavior
Measured: throughout the sedation session
Secondary outcomes (2)
Onset of sedation
The time taken for sedative drugs to start their action will be recorded using a stopwatch
Measured: during the sedation procedure (after drug administration until reaching satisfactory sedation)
Level of sedation
The level of sedation Agitated will be scored using a Five point sedation scale
- Agitated - Clinging to parent/crying
- Alert - Awake, not clinging to parent/no cry
- Calm - Sitting or lying comfortably with eyes spontaneously open eyes spontaneously closed but responds
- Drowsy: Comfortable with minor stimuli
- Asleep: Eyes closed, arousable, does not respond to minor stimuli.
Measured: during the sedation procedure (after drug administration until reaching satisfactory sedation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start10 Nov 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Amira A ElKhatib, PhD, Principal investigator, Kafrelsheikh University, Kafrelsheikh, EgyptYousr Nader, MSc, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883150
- Sponsor's protocol ID
- 210
- Status last verified
- Nov 2023
- First submitted
- 20 May 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05883150
- Acronym / sponsor ID
- 210
- Conditions
- Dental Sedation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the current study is to compare the effect of intranasal versus nebulized route of administration of midazolam as moderate sedative agents in preschoolers undergoing dental treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized Midazolam | Experimental | Drug: Nebulized Midazolam |
| Intranasal Midazolam | Active comparator | Drug: Intranasal Midazolam |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Frankl scale score 2.
- ASA I or II physical status.
- Dental intervention under local anesthesia not requiring more than 30 minutes.
- No previous dental experience.
- Parent/guardian's written consent.
Key exclusion criteria (4 listed)
- Dental treatment indicated under general anesthesia.
- Presence of facial or nasal deformities.
- History of neurological or cognitive alterations.
- Mouth breathers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulized MidazolamAll the drug solutions will be freshly prepared on the day of sedation session. Depending on the dosage calculated from the weight of each child The sedative drug, the dosage will be diluted with an equal volume by adding distilled water. The child will be seated in an upright position on the dental chair. Before placing the mask of the nebulizer, the child will be coached into proper breathing pattern | Drug | Nebulized Midazolam |
| Intranasal MidazolamAll the drug solutions will be freshly prepared on the day of sedation session. Depending on the dosage calculated from the weight of each child, For children who will receive midazolam using the atomization device attached to a three-ml syringe, the child sitting reclined in knee-to-knee position. Half of the dose will be sprayed in the right nostril and the other half will be sprayed in the left nostril to double the absorptive surface area by short and quick puffs | Drug | Intranasal Midazolam |
Primary outcome
Behavior rating
Time frame: throughout the sedation session
This will be recorded using the Modified Houpt scale for behavior rating; Sleep, head/oral resistance, crying and overall behavior will be scored on a 6-point scale ranging from 1-6 with higher scores indicating better behavior
2 secondary outcomes
Onset of sedation
Time frame: during the sedation procedure (after drug administration until reaching satisfactory sedation)
Level of sedation
Time frame: during the sedation procedure (after drug administration until reaching satisfactory sedation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
Related trials for Dental Sedation
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Enrolling by invitationObservational study
Treating Children With Extensive Dental Needs
Dental Caries, Tooth Extraction
RecruitingPhase 4
Sedation Versus Protective Stabilization for Pediatric Dental Treatment
Child Behavior, Dental Caries in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira A ElKhatib, PhD principal investigator
Kafrelsheikh University, Kafrelsheikh, Egypt
Yousr Nader, MSc principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nebulized Midazolam and Intranasal Midazolam in people with Dental Sedation, run by Nourhan M.Aly at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior rating (time frame: throughout the sedation session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.