Anti-anxiety AgentsPhase 2/3NCT04237532
Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment
A Phase 2/3 study testing Intranasal Dexmedetomidine and Sublingual Dexmedetomidine in people with Anti-anxiety Agents and Moderate Sedation, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
The aim of this study is to assess the efficacy of Dexmedetomidine drug either used sublingually or intranasally in managing healthy children during dental treatment Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Anti-anxiety Agents, Moderate Sedation
- What is being tested?
- Intranasal Dexmedetomidine and Sublingual Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Aug 2019to 10 Aug 2020
- 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 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Frankl behavior rating score 2.
- ASA I physical status.
- Dental intervention under local anesthesia not requiring more than 30 minutes.
- No previous dental experience.
- Parent/guardian written consent.
Who cannot join
- Dental treatment indicated requiring general anesthesia.
- Mouth breathers.
- Patients with acute upper respiratory illness.
- Medically compromised patients.
- Cognitively impaired patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment (A Randomized Controlled Clinical Trial)
The aim of this study is to assess the efficacy of Dexmedetomidine drug either used sublingually or intranasally in managing healthy children during dental treatment
Read the detailed description
Each child should fulfill the requirements of having a dental condition which needs treatment in two dental sessions, where each session should not exceed thirty minutes. At the first visit ,either sublingual or intranasal Dexmedetomidine will be used, while at the second visit the alternate route will be implemented in a cross-over design. At least one week interval between the two visits will be secured.
- Conditions
- Anti-anxiety Agents, Moderate Sedation
- Being tested
- Intranasal Dexmedetomidine, Sublingual Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal DexmedetomidineDrug
The mucosal atomizing device will be used intranasally where the sedative drug will be equally divided and sprayed into each nostril while the child semi reclined position.
Sublingual DexmedetomidineDrug
The mucosal atomizing device will be used sublingually by asking the child to touch their maxillary incisor teeth with the tip of their tongue and instruct the child not to swallow the drug for 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Dexmedetomidine | Experimental | Not described Receives: Drug: Intranasal Dexmedetomidine |
| Sublingual Dexmedetomidine | Experimental | Not described Receives: Drug: Sublingual Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of drug administration
Assessed by a 4 point Likert scale as follows: 1 (Good) the child accepted the drug without any refusal. 2 (fair) the child accepted the drug with some verbal resistance. 3 (poor) the child accepted the drug with some physical resistance. 4 (refused) the child refused but drug administration was possible after persuation.
Measured: during the sedation procedure
Level of Sedation
Time taken by both routes to reach the desired level of sedation using Wilton et al sedation scale and it is scored as follows: 1. Agitated: Clinging parent and/or crying. 2.Alert: Awake, but not clinging to parent may whimper but not crying. 3.Calm: Sitting or lying comfortably with eyes spontaneously open. 4.Drowsy: Sitting or lying comfortably with eyes spontaneously closing but responds to minor stimulation. 5. Asleep: Eyes closed, rousable, does not respond to minor stimulation.
Measured: during the sedation procedure
Anxiety level
Anxiety level during local anesthesia administration will be evaluated using Venham's clinical anxiety scale. 0: Relaxed child, 1: Uneasy, concerned, 2:Child appears scared, 3:Shows reluctance to enter situation, difficulty in correctly assessing situational threat, 4:Anxiety interferes with ability to assess situation.
Measured: during the sedation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start27 Aug 2019
- Primary completion1 Aug 2020
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anti-anxiety AgentsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will be randomized controlled clinical trial with a cross over design where each patient will serve as his/her own control
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- May Shaat, BDS, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptNiveen Bakry, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptDalia M Talaat, PhD, Study director, Faculty of Dentistry, Alexandria University, EgyptAhmed M El-Shafei, PhD, Study director, Faculty of Medicine, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237532
- Sponsor's protocol ID
- Sublingual vs intranasal DEX
- Status last verified
- Oct 2020
- First submitted
- 17 Jan 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
al-Rakaf H, Bello LL, Turkustani A, Adenubi JO. Intra-nasal midazolam in conscious sedation of young paediatric dental patients. Int J Paediatr Dent. 2001 Jan;11(1):33-40. doi: 10.1046/j.1365-263x.2001.00237.x.
PubMed 11309871Wilton NC, Leigh J, Rosen DR, Pandit UA. Preanesthetic sedation of preschool children using intranasal midazolam. Anesthesiology. 1988 Dec;69(6):972-5. doi: 10.1097/00000542-198812000-00032. No abstract available.
PubMed 3195771Venham LL, Gaulin-Kremer E, Munster E, Bengston-Audia D, Cohan J. Interval rating scales for children's dental anxiety and uncooperative behavior. Pediatr Dent. 1980 Sep;2(3):195-202. No abstract available.
PubMed 6938934
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04237532
- Acronym / sponsor ID
- Sublingual vs intranasal DEX
- Conditions
- Anti-anxiety Agents, Moderate Sedation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 23 Jan 2020 (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 this study is to assess the efficacy of Dexmedetomidine drug either used sublingually or intranasally in managing healthy children during dental treatment
Detailed description
Each child should fulfill the requirements of having a dental condition which needs treatment in two dental sessions, where each session should not exceed thirty minutes. At the first visit ,either sublingual or intranasal Dexmedetomidine will be used, while at the second visit the alternate route will be implemented in a cross-over design. At least one week interval between the two visits will be secured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be randomized controlled clinical trial with a cross over design where each patient will serve as his/her own control
| Arm | Type | Receives |
|---|---|---|
| Intranasal Dexmedetomidine | Experimental | Drug: Intranasal Dexmedetomidine |
| Sublingual Dexmedetomidine | Experimental | Drug: Sublingual Dexmedetomidine |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Frankl behavior rating score 2.
- ASA I physical status.
- Dental intervention under local anesthesia not requiring more than 30 minutes.
- No previous dental experience.
- Parent/guardian written consent.
Key exclusion criteria (5 listed)
- Dental treatment indicated requiring general anesthesia.
- Mouth breathers.
- Patients with acute upper respiratory illness.
- Medically compromised patients.
- Cognitively impaired patients.
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 |
|---|---|---|
| Intranasal DexmedetomidineThe mucosal atomizing device will be used intranasally where the sedative drug will be equally divided and sprayed into each nostril while the child semi reclined position. | Drug | Intranasal Dexmedetomidine |
| Sublingual DexmedetomidineThe mucosal atomizing device will be used sublingually by asking the child to touch their maxillary incisor teeth with the tip of their tongue and instruct the child not to swallow the drug for 30 seconds. | Drug | Sublingual Dexmedetomidine |
Primary outcome
Acceptance of drug administration
Time frame: during the sedation procedure
Assessed by a 4 point Likert scale as follows: 1 (Good) the child accepted the drug without any refusal. 2 (fair) the child accepted the drug with some verbal resistance. 3 (poor) the child accepted the drug with some physical resistance. 4 (refused) the child refused but drug administration was possible after persuation.
Level of Sedation
Time frame: during the sedation procedure
Time taken by both routes to reach the desired level of sedation using Wilton et al sedation scale and it is scored as follows: 1. Agitated: Clinging parent and/or crying. 2.Alert: Awake, but not clinging to parent may whimper but not crying. 3.Calm: Sitting or lying comfortably with eyes spontaneously open. 4.Drowsy: Sitting or lying comfortably with eyes spontaneously closing but responds to minor stimulation. 5. Asleep: Eyes closed, rousable, does not respond to minor stimulation.
Anxiety level
Time frame: during the sedation procedure
Anxiety level during local anesthesia administration will be evaluated using Venham's clinical anxiety scale. 0: Relaxed child, 1: Uneasy, concerned, 2:Child appears scared, 3:Shows reluctance to enter situation, difficulty in correctly assessing situational threat, 4:Anxiety interferes with ability to assess situation.
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 29 Oct 2020.
- Background: PubMed 11309871al-Rakaf H, Bello LL, Turkustani A, Adenubi JO. Intra-nasal midazolam in conscious sedation of young paediatric dental patients. Int J Paediatr Dent. 2001 Jan;11(1):33-40. doi: 10.1046/j.1365-263x.2001.00237.x.
- Background: PubMed 3195771Wilton NC, Leigh J, Rosen DR, Pandit UA. Preanesthetic sedation of preschool children using intranasal midazolam. Anesthesiology. 1988 Dec;69(6):972-5. doi: 10.1097/00000542-198812000-00032. No abstract available.
- Background: PubMed 6938934Venham LL, Gaulin-Kremer E, Munster E, Bengston-Audia D, Cohan J. Interval rating scales for children's dental anxiety and uncooperative behavior. Pediatr Dent. 1980 Sep;2(3):195-202. No abstract available.
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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.
May Shaat, BDS principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Niveen Bakry, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
Dalia M Talaat, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
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 Intranasal Dexmedetomidine and Sublingual Dexmedetomidine in people with Anti-anxiety Agents and Moderate 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 5 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 29 Oct 2020. 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?
Acceptance of drug administration (time frame: during the sedation procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04237532, which also lists 3 linked publications.
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 29 Oct 2020.