Traumatic Brain InjuryNCT01900405
Intranasal Dexmedetomidine Sedation for Pediatric CT Imaging
An observational study of Traumatic Brain Injury and Children, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study has the objective to determine if intranasal dexmedetomidine, a sedative, is suitable for pediatric sedation in children undergoing tomographic scans. Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Traumatic Brain Injury, Children
- What is being tested?
- Dexmedetomidine
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2013to Jan 2014
- 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 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: The University Hospital of University of Sao Paulo is a secondary teaching hospital. The Pediatric Emergency Department has over 6,000 consultations per month, mainly in children without underlying diseases. Respiratory diseases are the leading causes of hospital admission. During the study period, any children presented to the emergency department with indication for a CT scanning will be recruited for IN dexmedetomidine, respecting the exclusion criteria displayed below.
Who may be able to join
- Children between 1 month to 15 years old undergoing CT scans in the pediatric emergency department
Who cannot join
- Glasgow coma scale < 13
- Epistaxis or suspected base skull fracture
- Use of contrast or need for an IV line before sedation
- Uncontrolled gastroesophageal reflux or vomiting
- Current (or within past 3 months) history of apnea of prematurity requiring an apnea monitor
- Acute, unstable respiratory disease
Show all 12Show fewer
- Unstable cardiac status
- Craniofacial anomaly
- Medication use: digoxin
- Moya Moya Disease
- New onset stroke
- American Society of Anesthesiologists physical status ≥3
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University Hospital, University of Sao Paulo
São Paulo, São Paulo, 05508000
Alfredo Gilio, MD, PhD, +55 11 30919200 ext. 919409, aegilio@uol.com.br
Eduardo Mekitarian Filho, MD, PhD
About this study
Official title: Intranasal Dexmedetomidine Sedation for Pediatric Computerized Tomography Imaging
This study has the objective to determine if intranasal dexmedetomidine, a sedative, is suitable for pediatric sedation in children undergoing tomographic scans.
Read the detailed description
Invasive procedures for diagnosis in children are a routine part of an emergency care department. Most of these procedures are painful and uncomfortable for both the child and for their families, and impossible to be performed without patient immobilization. Thus, procedural sedation is critical to this end. Procedural sedation can be defined as the use of sedatives, analgesics, or dissociative drugs for anxiolysis, analgesia, sedation and motor control during painful procedures.
The increasing demand of pediatric emergency services and, consequently, the performance of procedures that require sedation, made it impossible for universal coverage of anesthesiologists in such procedures. As a result, a wide variety of drugs, sedation techniques and different degrees of effectiveness and adverse effects of sedation, such as irritability and sedation failure are described.
Particularly in children who need CT scan, there is usually no need for venous access for sedation. However, our most used drug, chloral hydrate, was abandoned in most centers outside the country. When administered orally, the drug produces malaise and vomiting, and gastric mucosal irritation, in addition, the rectal absorption is unpredictable. Additionally, in recent years increasing importance has been given to the fact that the drug be related, in vitro, the increased carcinogenicity in mice by cellular structural change, which is leading to the ban of same drug in the United States and in some european countries.
Dexmedetomidine is a highly selective alpha-2 agonist receptors, which has the advantage of mimicking natural sleep, according to electroencephalographic studies, with low incidence of adverse events. Its application as a sedative in pediatric procedures, as well as pre-anesthetic medication, has been increasingly described according to recent studies. The intranasal route has been used with the advantage of avoiding a venous line or intramuscular injection, with good results; however, it hasn't been described yet in children undergoing CT scans.
Thus, this work is justified to describe, in a pioneering way, the use of intranasal dexmedetomidine for sedation for CT, documenting its efficacy and safety in a specific cohort of patients sedated for this purpose.
- Conditions
- Traumatic Brain Injury, Children
- Being tested
- Dexmedetomidine
- Keywords
- Dexmedetomidine, Administration, Intranasal, Children, Computerized Tomography
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex (brand name)
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | All children undergoing Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of sedation failure with intranasal dexmedetomidine for sedation for pediatric CT imaging
Main outcome for this research is to know if IN dexmedetomidine is effective for adequate sedation in children undergoing CT scannings. This will be reported as percentage of failed sedations, if they occur. Failed sedations will be defined if after a initial 2.5 mcg/kg dose along with another 0.5 mcg/kg dose after 15 minutes, the child does not sedate.
Measured: Failure to sedate will be defined as non-completion of CT imaging after 2 nasal doses of dexmedetomidine (2.5 mcg/kg at admission; 0.5 mcg/kg after 15 minutes if not sedated).
Secondary outcomes (1)
Safety of IN dexmedetomidine for pediatric CT imaging
Patients will be fully monitored every five minutes after IN dexmedetomidine administration, with heart rate, respiratory rate, non-invasive blood pressure and pulse oximetry. Any adverse events will be reported.
Measured: At admission and every 5 minutes after sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013 (estimated)
- Study completionJan 2014 (estimated)
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 Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital
- Responsible party
- Principal investigator, Eduardo Mekitarian Filho, University of Sao Paulo
- Investigators
- Keira Mason, MD, Study director, Boston Children's Hospital, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900405
- Sponsor's protocol ID
- USPDex
- Status last verified
- Jul 2013
- First submitted
- 9 Jul 2013
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Mekitarian Filho E, Robinson F, de Carvalho WB, Gilio AE, Mason KP. Intranasal dexmedetomidine for sedation for pediatric computed tomography imaging. J Pediatr. 2015 May;166(5):1313-1315.e1. doi: 10.1016/j.jpeds.2015.01.036. Epub 2015 Mar 6.
PubMed 25748567
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine Sedation for Pediatric Computerized Tomography Imaging
- ClinicalTrials.gov ID
- NCT01900405
- Acronym / sponsor ID
- USPDex
- Conditions
- Traumatic Brain Injury, Children
- Keywords
- Dexmedetomidine, Administration, Intranasal, Children, Computerized Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Boston Children's Hospital
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 16 Jul 2013 (estimated)
- 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.
This study has the objective to determine if intranasal dexmedetomidine, a sedative, is suitable for pediatric sedation in children undergoing tomographic scans.
Detailed description
Invasive procedures for diagnosis in children are a routine part of an emergency care department. Most of these procedures are painful and uncomfortable for both the child and for their families, and impossible to be performed without patient immobilization. Thus, procedural sedation is critical to this end. Procedural sedation can be defined as the use of sedatives, analgesics, or dissociative drugs for anxiolysis, analgesia, sedation and motor control during painful procedures.
The increasing demand of pediatric emergency services and, consequently, the performance of procedures that require sedation, made it impossible for universal coverage of anesthesiologists in such procedures. As a result, a wide variety of drugs, sedation techniques and different degrees of effectiveness and adverse effects of sedation, such as irritability and sedation failure are described.
Particularly in children who need CT scan, there is usually no need for venous access for sedation. However, our most used drug, chloral hydrate, was abandoned in most centers outside the country. When administered orally, the drug produces malaise and vomiting, and gastric mucosal irritation, in addition, the rectal absorption is unpredictable. Additionally, in recent years increasing importance has been given to the fact that the drug be related, in vitro, the increased carcinogenicity in mice by cellular structural change, which is leading to the ban of same drug in the United States and in some european countries.
Dexmedetomidine is a highly selective alpha-2 agonist receptors, which has the advantage of mimicking natural sleep, according to electroencephalographic studies, with low incidence of adverse events. Its application as a sedative in pediatric procedures, as well as pre-anesthetic medication, has been increasingly described according to recent studies. The intranasal route has been used with the advantage of avoiding a venous line or intramuscular injection, with good results; however, it hasn't been described yet in children undergoing CT scans.
Thus, this work is justified to describe, in a pioneering way, the use of intranasal dexmedetomidine for sedation for CT, documenting its efficacy and safety in a specific cohort of patients sedated for this purpose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | – | Drug: DexmedetomidineAll children undergoing |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The University Hospital of University of Sao Paulo is a secondary teaching hospital. The Pediatric Emergency Department has over 6,000 consultations per month, mainly in children without underlying diseases. Respiratory diseases are the leading causes of hospital admission. During the study period, any children presented to the emergency department with indication for a CT scanning will be recruited for IN dexmedetomidine, respecting the exclusion criteria displayed below.
Key inclusion criteria (1 listed)
- Children between 1 month to 15 years old undergoing CT scans in the pediatric emergency department
Key exclusion criteria (12 listed)
- Glasgow coma scale < 13
- Epistaxis or suspected base skull fracture
- Use of contrast or need for an IV line before sedation
- Uncontrolled gastroesophageal reflux or vomiting
- Current (or within past 3 months) history of apnea of prematurity requiring an apnea monitor
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 |
|---|---|---|
| DexmedetomidineAlso: Precedex (brand name) | Drug | Dexmedetomidine |
Primary outcome
Rates of sedation failure with intranasal dexmedetomidine for sedation for pediatric CT imaging
Time frame: Failure to sedate will be defined as non-completion of CT imaging after 2 nasal doses of dexmedetomidine (2.5 mcg/kg at admission; 0.5 mcg/kg after 15 minutes if not sedated).
Main outcome for this research is to know if IN dexmedetomidine is effective for adequate sedation in children undergoing CT scannings. This will be reported as percentage of failed sedations, if they occur. Failed sedations will be defined if after a initial 2.5 mcg/kg dose along with another 0.5 mcg/kg dose after 15 minutes, the child does not sedate.
1 secondary outcome
Safety of IN dexmedetomidine for pediatric CT imaging
Time frame: At admission and every 5 minutes after sedation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
- Derived from this study: PubMed 25748567Mekitarian Filho E, Robinson F, de Carvalho WB, Gilio AE, Mason KP. Intranasal dexmedetomidine for sedation for pediatric computed tomography imaging. J Pediatr. 2015 May;166(5):1313-1315.e1. doi: 10.1016/j.jpeds.2015.01.036. Epub 2015 Mar 6.
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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.
Keira Mason, MD study director
Boston Children's Hospital, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Children, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 16 Jul 2013. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Mekitarian Filho, MD, PhD (+55 11 30919333 ext. 919333, emf2002@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of sedation failure with intranasal dexmedetomidine for sedation for pediatric CT imaging (time frame: Failure to sedate will be defined as non-completion of CT imaging after 2 nasal doses of dexmedetomidine (2.5 mcg/kg at admission; 0.5 mcg/kg after 15 minutes if not sedated).). 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 NCT01900405, 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 16 Jul 2013.