DexmedetomidineNCT03220880
Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures
An observational study of Dexmedetomidine and Sedation, run by Columbia University at 8 sites in United States.
Trial summary
Specific Aim 1: To describe the adequacy of sedation associated with different regimens of IN DEX in children undergoing non-painful procedures. This aim will test the working hypothesis that IN DEX regimens are effective for producing sedation adequate for completion of non-painful procedures in children. Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Dexmedetomidine, Sedation
- What is being tested?
- Intranasal dexmedetomidine
- How many people
- 578 participants
- Where
- 8 sitesUnited States
- Study dates
- 4 Sep 2018to 31 Jan 2020
- Phase
- Observational
- 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 2 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children undergoing sedation using intranasal dexmedetomidine for non-painful procedures.
Who may be able to join
- Children 2 months to 17 years (i.e. before their 18th birthday)
- Child will be receiving intranasal dexmedetomidine as part of their usual medical care
- Child will be undergoing a non-painful medical procedure, which includes (but is not limited to): MRI, CT scans, ABR/BAER, echocardiograms, and EEGs.
Who cannot join
- Known allergy to dexmedetomidine
- Known abnormal renal or hepatic function
- Known cardiac conduction abnormality or heart block
- Current use of digoxin or beta-blockers
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Boston Children's Hospital
Boston, Massachusetts, 02115
UNC Children's Hospital
Chapel Hill, North Carolina, 27514
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Santa Clara Valley Medical Center
San Jose, California, 95128
Southern Illinois University Healthcare
Springfield, Illinois, 62794
About this study
Official title: Clinical Characteristics of Intranasal Dexmedetomidine for Sedation in Children Undergoing Non-painful Procedures
Specific Aim 1: To describe the adequacy of sedation associated with different regimens of IN DEX in children undergoing non-painful procedures. This aim will test the working hypothesis that IN DEX regimens are effective for producing sedation adequate for completion of non-painful procedures in children.
Specific Aim 2: To describe the temporal characteristics associated with varied regimens of IN DEX in children undergoing non-painful procedures, such as time to onset of adequate sedation; time to procedure start; and time from procedure end to meeting discharge criteria. This aim will test the working hypothesis that IN DEX regimens have temporal characteristics that are favourable for sedating children for non-painful procedures.
Specific Aim 3: To describe the adverse events associated with varied regimens of IN DEX in children undergoing non-painful procedures. This aim will test the working hypothesis that IN DEX regimens have a low incidence of adverse events.
Read the detailed description
Dexmedetomidine (DEX) is an alpha-2 receptor agonist with sedative, anxiolytic, and analgesics properties. DEX has been used extensively for sedation in children to facilitate different non-painful procedures, such magnetic resonance imaging (MRI), auditory brainstem response (ABR) tests, and computed tomography (CT) scans. In particular, DEX can be administered by the intranasal (IN) route. Intranasal administration has the benefits of being both effective and needle-free, of which the latter makes it less distressing to children compared to sedatives administered by the intravenous (IV) route. There is a gap of knowledge, however, regarding the ideal regimen of IN DEX for providing optimal procedural sedation in children undergoing non-painful procedures. There is a large variation in practice using IN DEX, both regarding the dose and the use of adjunct medications. It is also unknown whether regimens should vary based on patient factors such as age. There is no clear evidence to define best practice when using IN DEX to provide sedation in this population to achieve the desired outcomes most relevant to clinicians. The rationale of the proposed investigation is that by conducting an exploratory study to measure clinical outcomes associated with IN DEX, the investigators can begin to identify trends and differences that will lay the foundation for randomized clinical trials to identify the ideal regimen for IN DEX when providing sedation for non-painful procedures. This will then allow the investigators to compare IN DEX, at its best, to other sedatives so that the sedative and regimen associated with the best outcomes relevant to sedation of children undergoing non-painful procedures can be determined.
- Conditions
- Dexmedetomidine, Sedation
- Being tested
- Intranasal dexmedetomidine
- Keywords
- Dexmedetomidine, Sedation, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal dexmedetomidineDrug
Intranasal dexemedetomidine (100 mcg/mL), 0.5 to 4 mcg/kg
| Study group | Role | What they receive |
|---|---|---|
| Intranasal dexmedetomidine | Intranasal dexmedetomidine (100 mcg/mL), 0.5 to 4 mcg/kg Receives: Drug: Intranasal dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of sedation
Pediatric Sedation State Scale
Measured: 1 hour
Secondary outcomes (2)
Time to onset of adequate sedation
Time in minutes after administration of IN DEX to achieve a University of Michigan Sedation Scale (UMSS) score of 3 or more
Measured: 1 hour
Time to discharge
Time in minutes after procedure end to achieving Modified Aldrete Scoring System (MASS) score of 9 or greater, or baseline MASS score.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start4 Sep 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta, University of Pittsburgh, Children's Hospital Medical Center, Cincinnati, UNC Children's Hospital, Santa Clara Valley Medical Center, Baylor College of Medicine, HSHS St. John's Hospital, Boston Children's Hospital
- Responsible party
- Principal investigator, Daniel S Tsze, MD, MPH, Columbia University
- Investigators
- Daniel S Tsze, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220880
- Sponsor's protocol ID
- AAAR5010
- Status last verified
- Sep 2021
- First submitted
- 14 Jul 2017
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
Tsze DS, Rogers AP, Baier NM, Paquin JR, Majcina R, Phelps JR, Hollenbeck A, Sulton CD, Cravero JP. Clinical Outcomes Associated With Intranasal Dexmedetomidine Sedation in Children. Hosp Pediatr. 2023 Mar 1;13(3):223-243. doi: 10.1542/hpeds.2022-007007.
PubMed 36810939
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Intranasal Dexmedetomidine for Sedation in Children Undergoing Non-painful Procedures
- ClinicalTrials.gov ID
- NCT03220880
- Acronym / sponsor ID
- AAAR5010
- Conditions
- Dexmedetomidine, Sedation
- Keywords
- Dexmedetomidine, Sedation, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta, University of Pittsburgh, Children's Hospital Medical Center, Cincinnati, UNC Children's Hospital, Santa Clara Valley Medical Center, Baylor College of Medicine, HSHS St. John's Hospital, Boston Children's Hospital
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 18 Jul 2017 (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.
Specific Aim 1: To describe the adequacy of sedation associated with different regimens of IN DEX in children undergoing non-painful procedures. This aim will test the working hypothesis that IN DEX regimens are effective for producing sedation adequate for completion of non-painful procedures in children.
Specific Aim 2: To describe the temporal characteristics associated with varied regimens of IN DEX in children undergoing non-painful procedures, such as time to onset of adequate sedation; time to procedure start; and time from procedure end to meeting discharge criteria. This aim will test the working hypothesis that IN DEX regimens have temporal characteristics that are favourable for sedating children for non-painful procedures.
Specific Aim 3: To describe the adverse events associated with varied regimens of IN DEX in children undergoing non-painful procedures. This aim will test the working hypothesis that IN DEX regimens have a low incidence of adverse events.
Detailed description
Dexmedetomidine (DEX) is an alpha-2 receptor agonist with sedative, anxiolytic, and analgesics properties. DEX has been used extensively for sedation in children to facilitate different non-painful procedures, such magnetic resonance imaging (MRI), auditory brainstem response (ABR) tests, and computed tomography (CT) scans. In particular, DEX can be administered by the intranasal (IN) route. Intranasal administration has the benefits of being both effective and needle-free, of which the latter makes it less distressing to children compared to sedatives administered by the intravenous (IV) route. There is a gap of knowledge, however, regarding the ideal regimen of IN DEX for providing optimal procedural sedation in children undergoing non-painful procedures. There is a large variation in practice using IN DEX, both regarding the dose and the use of adjunct medications. It is also unknown whether regimens should vary based on patient factors such as age. There is no clear evidence to define best practice when using IN DEX to provide sedation in this population to achieve the desired outcomes most relevant to clinicians. The rationale of the proposed investigation is that by conducting an exploratory study to measure clinical outcomes associated with IN DEX, the investigators can begin to identify trends and differences that will lay the foundation for randomized clinical trials to identify the ideal regimen for IN DEX when providing sedation for non-painful procedures. This will then allow the investigators to compare IN DEX, at its best, to other sedatives so that the sedative and regimen associated with the best outcomes relevant to sedation of children undergoing non-painful procedures can be determined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intranasal dexmedetomidine | – | Drug: Intranasal dexmedetomidineIntranasal dexmedetomidine (100 mcg/mL), 0.5 to 4 mcg/kg |
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children undergoing sedation using intranasal dexmedetomidine for non-painful procedures.
Key inclusion criteria (3 listed)
- Children 2 months to 17 years (i.e. before their 18th birthday)
- Child will be receiving intranasal dexmedetomidine as part of their usual medical care
- Child will be undergoing a non-painful medical procedure, which includes (but is not limited to): MRI, CT scans, ABR/BAER, echocardiograms, and EEGs.
Key exclusion criteria (4 listed)
- Known allergy to dexmedetomidine
- Known abnormal renal or hepatic function
- Known cardiac conduction abnormality or heart block
- Current use of digoxin or beta-blockers
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 dexmedetomidineIntranasal dexemedetomidine (100 mcg/mL), 0.5 to 4 mcg/kg | Drug | Intranasal dexmedetomidine |
Primary outcome
Adequacy of sedation
Time frame: 1 hour
Pediatric Sedation State Scale
2 secondary outcomes
Time to onset of adequate sedation
Time frame: 1 hour
Time to discharge
Time frame: 2 hours
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 Sep 2021.
- Derived from this study: PubMed 36810939Tsze DS, Rogers AP, Baier NM, Paquin JR, Majcina R, Phelps JR, Hollenbeck A, Sulton CD, Cravero JP. Clinical Outcomes Associated With Intranasal Dexmedetomidine Sedation in Children. Hosp Pediatr. 2023 Mar 1;13(3):223-243. doi: 10.1542/hpeds.2022-007007.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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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.
Daniel S Tsze, MD, MPH principal investigator
Columbia University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dexmedetomidine and Sedation, run by Columbia University at 8 sites in United States.
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 3 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 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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.
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?
Adequacy of sedation (time frame: 1 hour). 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 NCT03220880, which also lists 1 linked publication.
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 Sep 2021.