Overview
Sponsor-declared trial summary
Patients of the pediatric emergency room at Oulu University Hospital with any medical condition requiring a minor painful procedure such as i.v. cannulation or lumbar puncture are asked to join our study if they would seem to benefit from a sedative drug during the procedure.
Our objective is to determine if intranasal dexmedetomidine is a safe and effective sedative drug during small painful procedures in the pediatric emergency room.
Key facts
- Sponsor
- Oulu University Hospital
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 5 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Oulu University Hospital
External identifiers
- EU CT number
- 2024-518816-38-00
- EudraCT number
- 2017-001297-41
- ClinicalTrials.gov
- NCT03564093
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
Our objective is to determine if intranasal dexmedetomidine is a safe and effective sedative drug during small painful procedures in the pediatric emergency room.
Secondary objectives 1
- The duration of sedative effects of 1μg/kg intranasal dexmedetomidine spray is assessed.
Conditions and MedDRA coding
Patients of the pediatric emergency room at Oulu University Hospital with any medical condition requiring a minor painful procedure such as i.v. cannulation or lumbar puncture are asked to join our study if they would seem to benefit from a sedative drug during the procedure.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age 1-12 years
- Small procedure (e.g. i.v. cannulation or lumbar puncture)
- Presents at the Oulu University Hospital emergency room
Exclusion criteria 9
- Allergy to dexmedetomidine or any supplementary elements of the dexmedetomidine-solution
- II or III degree AV-blockage without pacemaker
- Uncontrollable hypotension
- Stroke
- Critically ill patients who are admitted to the Pediatric Intensive Care Unit
- Patients with clear cardiac or respiratory dysfunction
- Lowered level of consciousness
- Patients with increased risk of apnoeic events due to neurologic or metabolic conditions or extreme obesity
- Prior participation to the current study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The success of the procedure at the first attempt
Secondary endpoints 11
- The duration of the procedure
- Parents assessment of the patients comfortability during the procedure
- Patient's and physician's assessment of the experienced pain with Visual Analog Scale
- Assessment of pain levels of the patient with FLACC-scores
- Assessment of sedation levels of the patient with Comfort-B-scores
- Duration of crying
- The parents and the emergency room nurses are asked whether they think the patient recieved the experimental drug or placebo
- Blood pressure measured by manometer
- Respiratory rate assessed by capnometry
- Oxygen saturation is measured by pulse oxymetry
- Heart rate measured by ECG
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP101869653 · ATC
- Active substance
- Dexmedetomidine
- Route of administration
- INTRANASAL USE
- Max daily dose
- 100 µg microgram(s)
- Max total dose
- 100 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05CM18 — DEXMEDETOMIDINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Admnistered intra-nasally by using MAD nasal atomizing device.
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRANASAL USE
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oulu University Hospital
- Sponsor organisation
- Oulu University Hospital
- Address
- Kajaanintie 50
- City
- Oulu
- Postcode
- 90220
- Country
- Finland
Scientific contact point
- Organisation
- Oulu University Hospital
- Contact name
- The university help desk
Public contact point
- Organisation
- Oulu University Hospital
- Contact name
- The university help desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 112 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2024-11-05 | 2024-11-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Tutkimussuunnitelma | 2 |
| Recruitment arrangements (for publication) | INDEXER tiedonkeruulomake tutkijalle | 1 |
| Subject information and informed consent form (for publication) | Informed consent, 10-12 years of age | 6 |
| Subject information and informed consent form (for publication) | Informed consent, 6-9 years of age | 6 |
| Subject information and informed consent form (for publication) | Informed consent, parent | 6 |
| Subject information and informed consent form (for publication) | Tiedote | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Dexdor_Valmisteyhteenveto | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-08 | Finland | Acceptable 2024-11-05
|
2024-11-05 |