Emergence DeliriumPhase 3NCT03171740
Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children
A Phase 3 study testing Dexmedetomidine, Midazolam oral solution and Oral saline in people with Emergence Delirium, run by Brasilia University Hospital at 1 site in Brazil.
Trial summary
Study where children will receive one premedication, either intranasal dexmedetomidine or oral midazolam, to reduce agitation on emergence of anesthesia. The hypothesis is that dexmedetomidine is superior but previous studies lack quality. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Dexmedetomidine, Midazolam oral solution and Oral saline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2017to 15 Jan 2018
- Phase
- Phase 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Scheduled for amygdalectomy
- American Society of Anesthesiologists Physical Status PI or PII
- Absence of congenital neuropathy
- Absence of cardiac pathology (any)
- Intolerance to one of the studied drugs.
Who cannot join
- Protocol violation
- Need to transfer for ICU intubated
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University Hospital of Brasilia University
Brasília, Federal District, 7000000
About this study
Official title: Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children: Superiority Randomized Clinical Trial
Study where children will receive one premedication, either intranasal dexmedetomidine or oral midazolam, to reduce agitation on emergence of anesthesia. The hypothesis is that dexmedetomidine is superior but previous studies lack quality.
Read the detailed description
Children will be randomized to receive, either midazolam (0.5mg/kg) or dexmedetomidine (1mcg/kg), as anesthetic premedication. Emergence agitation will be assessed by PAED scale.
- Conditions
- Emergence Delirium
- Being tested
- Dexmedetomidine, Midazolam oral solution, Oral saline, Nasal saline
- Keywords
- Emergence Delirium, Emergence Agitation, premedication, dexmedetomidine, midazolam
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Intranasal dexmedetomidine, 1mcg/kg (it is a 100mcg/ml solution)
Midazolam oral solutionDrug
Oral midazolam, 0.5mg/kg (its a 2mg/ml solution)
Oral salineDrug
Also called 0.9% Saline solution
Oral saline, 0.25ml/kg
Nasal salineDrug
Also called 0.9% Saline solution
Nasal saline 0.01ml/kg
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Children will receive 1mcg/kg intranasal dexmedetomidine and oral saline, 30 minutes before going to operation theater. Receives: Drug: Dexmedetomidine; Drug: Oral saline |
| Midazolam oral solution | Active comparator | Children will receive 0,5mg/kg oral midazolam and intranasal saline, 30 minutes before going to operation theater. Receives: Drug: Midazolam oral solution; Drug: Nasal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence agitation
Anesthesiologist provider's reported score on PAED (Paediatric Anesthesia Emergence Scale) during the first 15 minutes after the extubation. The PAED consists of four items. Each item is scored 0-4 yielding a total between 0 and 20.
Measured: 15 minutes
Secondary outcomes (5)
Bradycardia
It is defined as a heart rate lower than the expected for the age or a drop higher than 30% of the patient's lowest previous heart rate registered. It will be measured using pletysmography and ECG beat-by-beat during the surgery and it will be true if it occurs at least once.
Measured: 2 hours
Hypotension
It is defined as a mean arterial pressure lower than the expected for the age or a drop higher than 30% of the patient's lowest previous mean arterial pressure registered. It will be measured using oscillatory method every 5 minutes during the surgery and it will be true if it occurs at least once.
Measured: 2 hours
Intraocular pressure
It will be measured in the first 15 minutes after the induction of general anesthesia using an ocular tonometer. It is measured in mmHg.
Measured: 15-minutes
Respiratory depression
Anesthesiologist provider's reported incidence respiratory depression in the child, before induction of general anesthesia. It will be true if the respiratory rate is slow for the age and the variable is dichotomic (true or false).
Measured: 30 minutes
Paradoxal agitation
Anesthesiologist provider's reported incidence paradoxal agitation in the child, before induction of general anesthesia. The assessment subjective and the variable is dichotomic (true or false).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Jun 2017
- Primary completion1 Dec 2017
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will receive an intranasal and an oral drug. One group will receive oral midazolam and intranasal saline, the other will receive oral saline and intranasal dexmededomedine.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brasilia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital
- Investigators
- Gabriel MN Guimarães, MD, Study chair, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171740
- Sponsor's protocol ID
- VictorSoutoAnestesiologia2017
- Status last verified
- Jul 2018
- First submitted
- 27 May 2017
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share the database used for analysis, without any variable that may help to identify individuals (such as name, register), to facilitate meta-analysis and re-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children: Superiority Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03171740
- Acronym / sponsor ID
- VictorSoutoAnestesiologia2017
- Conditions
- Emergence Delirium
- Keywords
- Emergence Delirium, Emergence Agitation, premedication, dexmedetomidine, midazolam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Brasilia University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 31 May 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.
Study where children will receive one premedication, either intranasal dexmedetomidine or oral midazolam, to reduce agitation on emergence of anesthesia. The hypothesis is that dexmedetomidine is superior but previous studies lack quality.
Detailed description
Children will be randomized to receive, either midazolam (0.5mg/kg) or dexmedetomidine (1mcg/kg), as anesthetic premedication. Emergence agitation will be assessed by PAED scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will receive an intranasal and an oral drug. One group will receive oral midazolam and intranasal saline, the other will receive oral saline and intranasal dexmededomedine.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine, Drug: Oral salineChildren will receive 1mcg/kg intranasal dexmedetomidine and oral saline, 30 minutes before going to operation theater. |
| Midazolam oral solution | Active comparator | Drug: Midazolam oral solution, Drug: Nasal salineChildren will receive 0,5mg/kg oral midazolam and intranasal saline, 30 minutes before going to operation theater. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Scheduled for amygdalectomy
- American Society of Anesthesiologists Physical Status PI or PII
- Absence of congenital neuropathy
- Absence of cardiac pathology (any)
- Intolerance to one of the studied drugs.
Key exclusion criteria (2 listed)
- Protocol violation
- Need to transfer for ICU intubated
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: PrecedexIntranasal dexmedetomidine, 1mcg/kg (it is a 100mcg/ml solution) | Drug | Dexmedetomidine |
| Midazolam oral solutionOral midazolam, 0.5mg/kg (its a 2mg/ml solution) | Drug | Midazolam oral solution |
| Oral salineAlso: 0.9% Saline solutionOral saline, 0.25ml/kg | Drug | Dexmedetomidine |
| Nasal salineAlso: 0.9% Saline solutionNasal saline 0.01ml/kg | Drug | Midazolam oral solution |
Primary outcome
Emergence agitation
Time frame: 15 minutes
Anesthesiologist provider's reported score on PAED (Paediatric Anesthesia Emergence Scale) during the first 15 minutes after the extubation. The PAED consists of four items. Each item is scored 0-4 yielding a total between 0 and 20.
5 secondary outcomes
Bradycardia
Time frame: 2 hours
Hypotension
Time frame: 2 hours
Intraocular pressure
Time frame: 15-minutes
Respiratory depression
Time frame: 30 minutes
Paradoxal agitation
Time frame: 30 minutes
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 13 Jul 2018.
- Individual participant dataSharing planned: Yes. Plan to share the database used for analysis, without any variable that may help to identify individuals (such as name, register), to facilitate meta-analysis and re-analysis.
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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.
Gabriel MN Guimarães, MD study chair
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine, Midazolam oral solution and Oral saline in people with Emergence Delirium, run by Brasilia University Hospital 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 5 inclusion and 2 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 13 Jul 2018. 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 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?
Emergence agitation (time frame: 15 minutes). 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 13 Jul 2018.