Procedural SedationPhase 4PINDEXNCT02955732
Pharmacological Characteristics of Intranasally Given Dexmedetomidine in Paediatric Patients
A Phase 4 study testing Dexmedetomidine in people with Procedural Sedation, run by Turku University Hospital at 1 site in Finland.
Trial summary
We aim to characterize the bioavailability and pharmacokinetics of dexmedetomidine after intranasal dosing employing pharmacometrics methods in otherwise healthy 1 month to 11 years of age children scheduled for minor surgery or other procedures requiring sedation or anesthesia. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Procedural Sedation
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2017to 10 Sep 2018
- 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 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. The child is scheduled for intra-articular drug injections, hernia repair, bronchoscopy or another similar minor procedure or magnetic resonance imaging requiring sedation or anesthesia
- 2. Guardians and patient (if relevant) with fluent skills in the Finnish or Swedish language (to understand the given information, to be able to give informed consent and communicate with the study personnel).
- 3. Age between 1 month and 12 years.
- 4. Normal developmental status including growth (SD -1.5-1.5)
- 5. Written informed consent from the guardian and the patient (when relevant).
Who cannot join
- 1. A previous history of intolerance to the study drug or to related compounds and additives
- 2. Prior drug therapy with dexmedetomidine in the 14 days prior to the study.
- 3. Use of any drugs known to cause enzyme induction or inhibition for a period of 30 days prior to the study, use of any natural products (including grapefruit products) for at least 14 days prior to the study and caffeine containing products for at least 24 hours prior to the study. The use of regular doses of paracetamol is allowed.
- 4. Existing or recent significant disease that could influence the study outcome or cause a health hazard for the subject if he/she would participate in the study.
- 5. Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
- 6. Clinically significant abnormal findings in physical examination or laboratory screening [routine haematology (haemoglobin, haematocrit, red blood cell count, white blood cell count, platelets), renal function tests (creatinine, urea) and liver function tests (bilirubin)].
Trial locations and contacts
1 site in 1 country.
Finland1 site
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
Turku, 20521
About this study
Official title: Bioavailability and Pharmacokinetics of Intranasal Dexmedetomidine in Children
We aim to characterize the bioavailability and pharmacokinetics of dexmedetomidine after intranasal dosing employing pharmacometrics methods in otherwise healthy 1 month to 11 years of age children scheduled for minor surgery or other procedures requiring sedation or anesthesia.
- Conditions
- Procedural Sedation
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDevice
Also called Dexdor
A 2-4 µg/kg dose of the study drug, 2 µg/kg of intranasal dexmedetomidine, will be administered using a LMA MAD Nasal™ -device approximately 20 min prior to planned sedation/anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal dex | Experimental | Dexmedetomidine 2-4 µg/kg alone Receives: Device: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability (%) of intranasally given dexmedetomidine
Measured: 4 hours
Secondary outcomes (3)
Change in hemodynamic parameter (blood pressure)
More than 30% change from the baseline in the blood pressure (measured in mmHg)
Measured: 6 hours
Change in hemodynamic parameter (heart rate)
More than 30% change from the baseline in the heart rate (measured in beats per minute)
Measured: 6 hours
Number of patients with adverse events as a measure of safety and tolerability
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start1 Jan 2017
- Primary completion30 Apr 2017
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku
- Responsible party
- Sponsor
- Investigators
- Panu Uusalo, MD, Principal investigator, Dept. Anaesthesilogy and Intensive Care, University of Turku and Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955732
- Sponsor's protocol ID
- T280/2016
- Acronym
- PINDEX
- Status last verified
- Sep 2018
- First submitted
- 3 Nov 2016
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Pharmacokinetics of Intranasal Dexmedetomidine in Children
- ClinicalTrials.gov ID
- NCT02955732
- Acronym / sponsor ID
- PINDEX / T280/2016
- Conditions
- Procedural Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku
- Study start
- 1 Jan 2017
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 4 Nov 2016 (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.
We aim to characterize the bioavailability and pharmacokinetics of dexmedetomidine after intranasal dosing employing pharmacometrics methods in otherwise healthy 1 month to 11 years of age children scheduled for minor surgery or other procedures requiring sedation or anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intranasal dex | Experimental | Device: DexmedetomidineDexmedetomidine 2-4 µg/kg alone |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 1. The child is scheduled for intra-articular drug injections, hernia repair, bronchoscopy or another similar minor procedure or magnetic resonance imaging requiring sedation or anesthesia
- 2. Guardians and patient (if relevant) with fluent skills in the Finnish or Swedish language (to understand the given information, to be able to give informed consent and communicate with the study personnel).
- 3. Age between 1 month and 12 years.
- 4. Normal developmental status including growth (SD -1.5-1.5)
- 5. Written informed consent from the guardian and the patient (when relevant).
Key exclusion criteria (6 listed)
- 1. A previous history of intolerance to the study drug or to related compounds and additives
- 2. Prior drug therapy with dexmedetomidine in the 14 days prior to the study.
- 3. Use of any drugs known to cause enzyme induction or inhibition for a period of 30 days prior to the study, use of any natural products (including grapefruit products) for at least 14 days prior to the study and caffeine containing products for at least 24 hours prior to the study. The use of regular doses of paracetamol is allowed.
- 4. Existing or recent significant disease that could influence the study outcome or cause a health hazard for the subject if he/she would participate in the study.
- 5. Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
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: DexdorA 2-4 µg/kg dose of the study drug, 2 µg/kg of intranasal dexmedetomidine, will be administered using a LMA MAD Nasal™ -device approximately 20 min prior to planned sedation/anesthesia. | Device | Intranasal dex |
Primary outcome
Relative bioavailability (%) of intranasally given dexmedetomidine
Time frame: 4 hours
3 secondary outcomes
Change in hemodynamic parameter (blood pressure)
Time frame: 6 hours
Change in hemodynamic parameter (heart rate)
Time frame: 6 hours
Number of patients with adverse events as a measure of safety and tolerability
Time frame: 6 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 12 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Panu Uusalo, MD principal investigator
Dept. Anaesthesilogy and Intensive Care, University of Turku and Turku University Hospital
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 in people with Procedural Sedation, run by Turku University Hospital at 1 site in Finland.
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 6 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 12 Sep 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 Finland. 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?
Relative bioavailability (%) of intranasally given dexmedetomidine (time frame: 4 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 12 Sep 2018.