PainPhase 4INDEXERNCT03564093
Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures
A Phase 4 study testing Intranasal Drug in people with Pain and Anesthesia, run by University of Oulu at 1 site in Finland.
Trial summary
The study objective is to determine if intranasal dexmedetomidine is a safe and effective sedative drug during small painful procedures in the pediatric emergency room. Patients of the pediatric emergency room at Oulu university hospital with any medical condition requiring a small painful procedure like i.v. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Pain, Anesthesia
- What is being tested?
- Intranasal Drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteFinland
- Study dates
- 15 Mar 2018to 10 Jun 2025
- 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 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 1-12 years at the Oulu University Hospital emergency room who would benefit from sedative medication during small painful procedures like i.v. cannulation or lumbar puncture are asked to take part in our study
Who cannot join
- Allergy to dexmedetomidine or any supplementary elements of the Dexdor®-solution
- II or III degree AV-blockage without pacemaker
- Uncontrollable hypotension
- Stroke
- Critically ill patients who are admitted to the PICU
- Patients with clear cardiac or respiratory dysfunction
Show all 9Show fewer
- Lowered level of consciousness
- Patients with increased risk of apnoeic events due to neurologic or metabolic conditions or extreme obesity
- A single patient can only take part in this study once.
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Oulu University Hospital
Oulu
Outi Peltoniemi, +35883155837, outi.peltoniemi@ppshp.fi
Miikka Tervonen, +35883158428, miikka.tervonen@ppshp.fi
About this study
Official title: Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures: Randomized Double-blinded Clinical Trial
The study objective is to determine if intranasal dexmedetomidine is a safe and effective sedative drug during small painful procedures in the pediatric emergency room. Patients of the pediatric emergency room at Oulu university hospital with any medical condition requiring a small painful procedure like i.v. cannulation or lumbar puncture are asked to join the investigator's study if they would seem to benefit from a sedative drug during the procedure. Patients are randomly assigned to treatment group receiving intranasal dexmedetomidine 1µg/kg and to placebo group receiving 4,5% saline solution. The primary outcome is the success of the procedure. Cardiovascular and respiratory effects, the pain experienced by the patient, sedation scores and duration of crying are also monitored.
- Conditions
- Pain, Anesthesia
- Being tested
- Intranasal Drug
- Keywords
- pediatrics, sedation, emergency room sedation, intranasal sedation, dexmedetomidine, intranasal dexmedetomidine, children, pediatric, pediatric sedation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal DrugDrug
Also called Dexmedetomidine
1µg/kg of dexmedetomidine is given 30 minutes prior to intravenous cannulation or lumbar puncture
Intranasal DrugDrug
Also called Placebo
Intranasal 4,5% saline is given as a placebo 30 minutes prior to intravenous cannulation or lumbar puncture
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | 1µg/kg intranasal dexmedetomidine Receives: Drug: Intranasal Drug |
| Placebo | Placebo comparator | 0,01ml/kg intranasal 4,5% saline Receives: Drug: Intranasal Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of the procedure
The success of the first attempt of the procedure (venous cannulation or lumbar puncture) is evaluated at the end of the first attempt of the procedure. Succesfulness of venous cannulation is tested by the doctor on call by flushing the cannula with saline. If the cannula works without complications the cannulation is successfull. Lumbar puncture is successfull if all the samples needed from the liquor are collected.
Measured: After the first attempt of the procedure. The procedure is attempted 30 minutes after the study drug administration.
Secondary outcomes (12)
The duration of the procedure
The duration of the procedure
Measured: The time from the start of the first attempt of the procedure to the success of the procedure. The procedure is attempted 30 after the study drug administration. Time from the first needle puncture to ending the procedure is recorded.
Parents assessment of the patients pain during the procedure
Parents assessment of the patients pain during the procedure on a visual analog scale. Parents fill in a questionnaire after the procedure is done. Questionnaire is returned to the research doctor during the follow up period.
Measured: Parents return a questionnaire within 2 hours after the study drug has been administered.
Patient pain VAS
Patients assessment of the experienced pain with Visual Analog Scale is asked in the end of the follow up period. Visual Analog Scale is a numerical value for the pain experienced by the patient ranging from 0 to 10.
Measured: The numerical value of VAS is asked in the end of the follow up period of 2 hours.
Patient pain FLACC
Assessment of pain levels of the patient with FLACC-scores. Assessment is done by the study doctor. FLACC is abbreviation of Faces Legs Activity Crying and Consolability scale. FLACC ranges from 0 to 10 as 0 being no pain at all and 10 being the most pain possible.
Measured: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Patient sedation level
Assessment of sedation levels of the patient with Comfort-B-scores. Assessment is done by the study doctor.Comfort-B is a sedation scale ranging from 6 to 30. The lower the score the more sedated a patient is.
Measured: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Duration of crying
Duration of the patients crying during and after the procedure. The duration of crying associated with the procedure is recorded in seconds and minutes.
Measured: Duration of crying during the time period from 25 minutes after the study drug administration for 30 minute time period in which the procedure is anticipated to be done.
Effectivity of the drug
The parents are asked in the end of the follow up period whether they think the patient received the experimental drug or placebo
Measured: The follow up period lasts 2 hours from the study drug administration.
Blood pressure
The systolic, diastolic and mean blood pressures are measured by manometer in every 5 minutes.
Measured: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Respiratory rate
Respiratory rate is assessed by capnometry continuously and the rate is documented in every 5 minutes.
Measured: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Oxygen saturation
Oxygen saturation is measured by pulse oxymetry continuously and the rate is documented in every 5 minutes
Measured: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Heart rate
Heart rate is measured by ECG continuously and the rate is documented in every 5 minutes
Measured: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Attempts needed to complete the procedure
The number attempts needed to complete the procedure is recorded.
Measured: After the successful attempt of the procedure. The first attempt of the procedure is done 30 minutes after the study drug administration. The assessment is done within 2 hours of the administration of the study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start15 Mar 2018
- Primary completion14 Mar 2025 (estimated)
- Study completion10 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Outi Peltoniemi, University of Oulu
- Investigators
- Outi Peltoniemi, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564093
- Sponsor's protocol ID
- INDEXER
- Acronym
- INDEXER
- Status last verified
- Dec 2023
- First submitted
- 13 Mar 2018
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures: Randomized Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT03564093
- Acronym / sponsor ID
- INDEXER / INDEXER
- Conditions
- Pain, Anesthesia
- Keywords
- pediatrics, sedation, emergency room sedation, intranasal sedation, dexmedetomidine, intranasal dexmedetomidine, children, pediatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 14 Mar 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 20 Jun 2018 (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.
The study objective is to determine if intranasal dexmedetomidine is a safe and effective sedative drug during small painful procedures in the pediatric emergency room. Patients of the pediatric emergency room at Oulu university hospital with any medical condition requiring a small painful procedure like i.v. cannulation or lumbar puncture are asked to join the investigator's study if they would seem to benefit from a sedative drug during the procedure. Patients are randomly assigned to treatment group receiving intranasal dexmedetomidine 1µg/kg and to placebo group receiving 4,5% saline solution. The primary outcome is the success of the procedure. Cardiovascular and respiratory effects, the pain experienced by the patient, sedation scores and duration of crying are also monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Intranasal Drug1µg/kg intranasal dexmedetomidine |
| Placebo | Placebo comparator | Drug: Intranasal Drug0,01ml/kg intranasal 4,5% saline |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients aged 1-12 years at the Oulu University Hospital emergency room who would benefit from sedative medication during small painful procedures like i.v. cannulation or lumbar puncture are asked to take part in our study
Key exclusion criteria (9 listed)
- Allergy to dexmedetomidine or any supplementary elements of the Dexdor®-solution
- II or III degree AV-blockage without pacemaker
- Uncontrollable hypotension
- Stroke
- Critically ill patients who are admitted to the PICU
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 |
|---|---|---|
| Intranasal DrugAlso: Dexmedetomidine1µg/kg of dexmedetomidine is given 30 minutes prior to intravenous cannulation or lumbar puncture | Drug | Dexmedetomidine |
| Intranasal DrugAlso: PlaceboIntranasal 4,5% saline is given as a placebo 30 minutes prior to intravenous cannulation or lumbar puncture | Drug | Placebo |
Primary outcome
Success of the procedure
Time frame: After the first attempt of the procedure. The procedure is attempted 30 minutes after the study drug administration.
The success of the first attempt of the procedure (venous cannulation or lumbar puncture) is evaluated at the end of the first attempt of the procedure. Succesfulness of venous cannulation is tested by the doctor on call by flushing the cannula with saline. If the cannula works without complications the cannulation is successfull. Lumbar puncture is successfull if all the samples needed from the liquor are collected.
12 secondary outcomes
The duration of the procedure
Time frame: The time from the start of the first attempt of the procedure to the success of the procedure. The procedure is attempted 30 after the study drug administration. Time from the first needle puncture to ending the procedure is recorded.
Parents assessment of the patients pain during the procedure
Time frame: Parents return a questionnaire within 2 hours after the study drug has been administered.
Patient pain VAS
Time frame: The numerical value of VAS is asked in the end of the follow up period of 2 hours.
Patient pain FLACC
Time frame: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Patient sedation level
Time frame: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Duration of crying
Time frame: Duration of crying during the time period from 25 minutes after the study drug administration for 30 minute time period in which the procedure is anticipated to be done.
Effectivity of the drug
Time frame: The follow up period lasts 2 hours from the study drug administration.
Blood pressure
Time frame: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Respiratory rate
Time frame: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Oxygen saturation
Time frame: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Heart rate
Time frame: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Attempts needed to complete the procedure
Time frame: After the successful attempt of the procedure. The first attempt of the procedure is done 30 minutes after the study drug administration. The assessment is done within 2 hours of the administration of the study drug.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- 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.
Outi Peltoniemi principal investigator
Oulu 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 Intranasal Drug in people with Pain and Anesthesia, run by University of Oulu 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 1 inclusion and 9 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 20 Dec 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Outi Peltoniemi (+35883155837, outi.peltoniemi@ppshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of the procedure (time frame: After the first attempt of the procedure. The procedure is attempted 30 minutes after the study drug administration.). 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 Dec 2023.