Deep SedationPhase 4NCT04509414
Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Deep Sedation and Dexmedetomidine, run by Peking University at 1 site in China.
Trial summary
It is important to choose an appropriate analgesia/sedation technique in pediatric dental treatment. Premedication combined with intravenous anesthesia is often used in deep sedation technique for pediatric dental treatment and it's a routine in most hospitals. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Deep Sedation, Dexmedetomidine
- What is being tested?
- Dexmedetomidine and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2020to 31 May 2022
- Phase
- Phase 4
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children in need of deep sedation for dental treatment aged 3-7 years.
- anticipated operation time 1-2hours
Who cannot join
- any known medical records with neural or mental disorder
- any known medical records with severe systemic disorder
- history of sedation drug administration in recent 1 months
- any known allergic history of dexmedetomidine, midazolam or propofol
- morbid obesity
- history of OSAHS or acute respiratory infection in 2 weeks
- other conditions which the attending considers to be unfit for the trial
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Hospital of Stomatology
Beijing, Beijing Municipality, 100081
About this study
Official title: Intranasal Dexmedetomidine Versus Midazolam for Premedication in Deep-sedated Pediatric Dental Patients: a Double-blinded, Prospective, Randomized Controlled Trial
It is important to choose an appropriate analgesia/sedation technique in pediatric dental treatment. Premedication combined with intravenous anesthesia is often used in deep sedation technique for pediatric dental treatment and it's a routine in most hospitals. Deep sedation has its unique advantages such as avoiding the airway damage with an enhanced recovery.
Dexmedetomidine is suitable for intranasal mucosal administration as a premedication drug. It has been proved with several beneficial characteristics in other clinical procedures.
This study intends to further explore the characteristics of nasal dexmedetomidine as premedication in pediatric oral treatment under deep sedation.
- Conditions
- Deep Sedation, Dexmedetomidine
- Being tested
- Dexmedetomidine, Midazolam
- Keywords
- deep sedation, pediatric, dexmedetomidine, dental treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
For dexmedetomidine group after ramdomization, an intranasal dose of 2ug/kg dexmedetomidine will be administrated.
MidazolamDrug
For midazolam group after ramdomization, an intranasal dose of 0.2mg/kg midazolam will be administrated.
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | 2ug/kg intranasal atomized dexmedetomidine Receives: Drug: Dexmedetomidine |
| midazolam | Active comparator | 0.2mg/kg intranasal atomized midazolam Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
venipuncture acceptance
acceptance while starting the IV line, at most 2 tries
Measured: Day 0
Secondary outcomes (11)
Observer's Assessment of Alertness/Sedation(MOAA/S) Score
sedation scoring with MOAA/S scale(from intranasal drug administration till discharge)
Measured: Day 0
remedial mask induction acceptance
acceptance of the mask induction（for those failed to start the IV before induction）
Measured: Day 0
propofol dosage
the total dosage of propofol used from induction till the end of the clinical treatment
Measured: Day 0
patients' discomfort
any adverse reaction or discomfort complaints of patients will be recorded, such as sneeze, blocked nose, bitter taste, dizziness, rhinalgia, etc.
Measured: up to 24 hours
hypoxemia
decreased oxygen saturation up to 90%, and the treatment will also be recorded(if any)
Measured: Day 0
peri-operative blood pressure
peri-operative blood pressure states
Measured: Day 0
peri-operative heart rate
peri-operative heart rate
Measured: Day 0
times of intra-operative airway assistance
Any intra-operative airway assistance in need which aims to improve ventilation will be recorded, including jaw lifting, suction, mask ventilation and intubation. Specific type of assistance will also be recorded in detail.
Measured: Day 0
post-operative pain
pain assessment with modified children's hospital of eastern Ontario pain score(m-CHEOPS) from the end of dental procedure till discharge
Measured: Day 0
post-operative agitation
emergence agitation assessment with Pediatric Anesthesia Emergence Delirium scale(PAED) from the end of dental procedure till discharge
Measured: Day 0
discharge time
time from the end of dental procedure till discharge
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start10 Apr 2020
- Primary completion1 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep SedationStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Xudong, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509414
- Sponsor's protocol ID
- PKUSSIRB-202056077
- Status last verified
- Feb 2023
- First submitted
- 23 Jul 2020
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine Versus Midazolam for Premedication in Deep-sedated Pediatric Dental Patients: a Double-blinded, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04509414
- Acronym / sponsor ID
- PKUSSIRB-202056077
- Conditions
- Deep Sedation, Dexmedetomidine
- Keywords
- deep sedation, pediatric, dexmedetomidine, dental treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 12 Aug 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.
It is important to choose an appropriate analgesia/sedation technique in pediatric dental treatment. Premedication combined with intravenous anesthesia is often used in deep sedation technique for pediatric dental treatment and it's a routine in most hospitals. Deep sedation has its unique advantages such as avoiding the airway damage with an enhanced recovery.
Dexmedetomidine is suitable for intranasal mucosal administration as a premedication drug. It has been proved with several beneficial characteristics in other clinical procedures.
This study intends to further explore the characteristics of nasal dexmedetomidine as premedication in pediatric oral treatment under deep sedation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: Dexmedetomidine2ug/kg intranasal atomized dexmedetomidine |
| midazolam | Active comparator | Drug: Midazolam0.2mg/kg intranasal atomized midazolam |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children in need of deep sedation for dental treatment aged 3-7 years.
- anticipated operation time 1-2hours
Key exclusion criteria (7 listed)
- any known medical records with neural or mental disorder
- any known medical records with severe systemic disorder
- history of sedation drug administration in recent 1 months
- any known allergic history of dexmedetomidine, midazolam or propofol
- morbid obesity
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 |
|---|---|---|
| DexmedetomidineFor dexmedetomidine group after ramdomization, an intranasal dose of 2ug/kg dexmedetomidine will be administrated. | Drug | dexmedetomidine |
| MidazolamFor midazolam group after ramdomization, an intranasal dose of 0.2mg/kg midazolam will be administrated. | Drug | midazolam |
Primary outcome
venipuncture acceptance
Time frame: Day 0
acceptance while starting the IV line, at most 2 tries
11 secondary outcomes
Observer's Assessment of Alertness/Sedation(MOAA/S) Score
Time frame: Day 0
remedial mask induction acceptance
Time frame: Day 0
propofol dosage
Time frame: Day 0
patients' discomfort
Time frame: up to 24 hours
hypoxemia
Time frame: Day 0
peri-operative blood pressure
Time frame: Day 0
peri-operative heart rate
Time frame: Day 0
times of intra-operative airway assistance
Time frame: Day 0
post-operative pain
Time frame: Day 0
post-operative agitation
Time frame: Day 0
discharge time
Time frame: Day 0
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 10 Feb 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Deep Sedation
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Recruiting
A Comparison of Pulsed Field Ablation (PFA) vs Cryoablation for Atrial Fibrillation Under Deep Sedation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Recruiting
Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
Mental Function
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Deep Sedation and Dexmedetomidine, run by Peking University at 1 site in China.
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 2 inclusion and 7 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 10 Feb 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 China. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
venipuncture acceptance (time frame: Day 0). 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 10 Feb 2023.