Traumatic Brain InjuryPhase 2NCT01402596
Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam
A Phase 2 study testing Midazolam and Chloral Hydrate in people with Traumatic Brain Injury and Computed Tomography, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Thousands of children receive sedation for diagnostic and therapeutic interventions annually, and this number is expected to increase. Children are at higher risk for sedation-related complications than adults. Read more about this study
- Who is it for?
- Ages 1 month to 3 years
- Conditions the study is for
- Traumatic Brain Injury, Computed Tomography, Procedural Sedation
- What is being tested?
- Midazolam and Chloral Hydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Aug 2012
- Phase
- Phase 2
- 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 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children undergoing CT scanning for TBI
Who cannot join
- epistaxis
- suspected or confirmed skull or nasal fracture
- Moderate to severe traumatic brain injury
- hemodynamically unstable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam - a Randomized Controlled Trial
Thousands of children receive sedation for diagnostic and therapeutic interventions annually, and this number is expected to increase. Children are at higher risk for sedation-related complications than adults. In different scenarios, multiple drugs are used to achieve sedation, each one with particular adverse events that must be monitored and reported.
Children that need CT scans for traumatic brain injuries often need sedation, without needing and IV line for that. Chloral hydrate is an hypnotic agent used since 1832 with low incidence of adverse events; however, despite its worldwide use, it's being abandoned due to bitter taste, long time of sedation onset, vomiting and mild sedation. Intranasal midazolam, on the other hand, produces high and fast concentrations on CSF with greater rates of success but probably with higher adverse events. There are no prospective studies with large series of patients using intranasal midazolam.
The aim of this study is to determine if nasal midazolam is a safer approach and more effective sedative regimen when compared to rectal chloral hydrate to children undergoing CT scans.
- Being tested
- Midazolam, Chloral Hydrate
- Keywords
- Deep Sedation, Pediatrics, Emergency Hospital Services, Midazolam, Chloral hydrate, Randomized controlled trial
- Medical subject headings
- Brain Injuries, Traumatic, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
0,4 mg per kg - intranasal midazolam - once
Chloral HydrateDrug
50 mg per kg, rectal
| Study group | Role | What they receive |
|---|---|---|
| Chloral hydrate | Active comparator | Children undergoing CT scanning will receive in this arm 50 mg per kg of rectal chloral hydrate. Receives: Drug: Chloral Hydrate |
| Midazolam | Active comparator | Children undergoing CT scanning will receive in this arm 0,4 mg/kg of nasal midazolam. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Such as hypoxemia, respiratory depression, vomiting, hypotension
Measured: Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours
Secondary outcomes (1)
Efficacy of both drugs
Patients vital signs and adverse events will be monitored through patient stay in the emergency department. Mean time after sedation is about three hours.
Variables collected include Ramsay score for sedation. To consider hospital discharge, we will try to validate Aldrette score and compare the scores between the two arms. Mean time to onset of sedation and time of emergency department stay will also be compared as a mark of efficacy of these two drugs.
Measured: Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Why it stopped: Institution decided on starting a new protocol of sedation, with another methods and that´s why this study has not started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Eduardo Mekitarian Filho, MSc, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402596
- Sponsor's protocol ID
- USP-Sed-001
- Status last verified
- Jul 2011
- First submitted
- 19 Jul 2011
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01402596
- Acronym / sponsor ID
- USP-Sed-001
- Keywords
- Deep Sedation, Pediatrics, Emergency Hospital Services, Midazolam, Chloral hydrate, Randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Institution decided on starting a new protocol of sedation, with another methods and that´s why this study has not started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 26 Jul 2011 (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.
Thousands of children receive sedation for diagnostic and therapeutic interventions annually, and this number is expected to increase. Children are at higher risk for sedation-related complications than adults. In different scenarios, multiple drugs are used to achieve sedation, each one with particular adverse events that must be monitored and reported.
Children that need CT scans for traumatic brain injuries often need sedation, without needing and IV line for that. Chloral hydrate is an hypnotic agent used since 1832 with low incidence of adverse events; however, despite its worldwide use, it's being abandoned due to bitter taste, long time of sedation onset, vomiting and mild sedation. Intranasal midazolam, on the other hand, produces high and fast concentrations on CSF with greater rates of success but probably with higher adverse events. There are no prospective studies with large series of patients using intranasal midazolam.
The aim of this study is to determine if nasal midazolam is a safer approach and more effective sedative regimen when compared to rectal chloral hydrate to children undergoing CT scans.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloral hydrate | Active comparator | Drug: Chloral HydrateChildren undergoing CT scanning will receive in this arm 50 mg per kg of rectal chloral hydrate. |
| Midazolam | Active comparator | Drug: MidazolamChildren undergoing CT scanning will receive in this arm 0,4 mg/kg of nasal midazolam. |
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children undergoing CT scanning for TBI
Key exclusion criteria (4 listed)
- epistaxis
- suspected or confirmed skull or nasal fracture
- Moderate to severe traumatic brain injury
- hemodynamically unstable
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 |
|---|---|---|
| Midazolam0,4 mg per kg - intranasal midazolam - once | Drug | Midazolam |
| Chloral Hydrate50 mg per kg, rectal | Drug | Chloral hydrate |
Primary outcome
Adverse Events
Time frame: Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours
Such as hypoxemia, respiratory depression, vomiting, hypotension
1 secondary outcome
Efficacy of both drugs
Time frame: Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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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.
Eduardo Mekitarian Filho, MSc study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Midazolam and Chloral Hydrate in people with Traumatic Brain Injury and Computed Tomography, 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 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: withdrawn, as of the sponsor's last update on 20 Jun 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.
What does this 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Adverse Events (time frame: Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours). 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 20 Jun 2013.