Juvenile Idiopathic ArthritisPhase 4NCT03069638
Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population
A Phase 4 study testing Dexmedetomidine and Sedatives/Hypnotics,Other in people with Juvenile Idiopathic Arthritis and Joint Inflammation, run by University of Oulu at 1 site in Finland.
Trial summary
The main objective of this study is to evaluate the effectivity of intranasal dexmedetomidine sedation during intra-articular injection therapy. Intranasal dexmedetomidine is compared with dinitrous oxide (N2O) which has already been proven safe and effective sedation method during painful procedures in pediatric… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Joint Inflammation
- What is being tested?
- Dexmedetomidine and Sedatives/Hypnotics,Other
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFinland
- Study dates
- 1 Feb 2017to 18 Dec 2023
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient age between ages 1year to 18 years
- A joint inflammation in 1-5 joints needing intra-articular corticosteroid injection diagnosed by pediatric rheumatologist
Who cannot join
- Patients under the age of 1year and over the age of 18years are excluded as well as patients needing injection therapy to more than 5 joints.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to evaluate the effectivity of intranasal dexmedetomidine sedation during intra-articular injection therapy. Intranasal dexmedetomidine is compared with dinitrous oxide (N2O) which has already been proven safe and effective sedation method during painful procedures in pediatric patients.
In earlier studies the median VAS during intra-articular corticosteroid injections with patients receiving nitrous oxide has been 3 (Uziel et al 2008). Study hypothesis is that with intranasal dexmedetomidine sedation the VAS pain levels will be 1 unit lower.
- Conditions
- Juvenile Idiopathic Arthritis, Joint Inflammation
- Being tested
- Dexmedetomidine, Sedatives/Hypnotics,Other
- Keywords
- sedation, pediatrics, intranasal sedation, dexmedetomidine, dinitrous oxide, intra-articular joint injection
- Medical subject headings
- Arthritis, Juvenile, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection)
Sedatives/Hypnotics,OtherDrug
Also called Dinitrous oxide
Inhaled dinitrous oxide as procedural sedation (intra-articular joint injection)
| Study group | Role | What they receive |
|---|---|---|
| Intranasal dexmedetomidine | Experimental | Dexmedetomidine is given once 4 micrograms per kilogram intranasally. If the sedation is not successful another 2 microgram per kilogram intranasal dose is given. Intravenous dexmedetomidine solution is administrated intranasally with MAD nasal drug delivery device and a syringe. Receives: Drug: Dexmedetomidine; Drug: Sedatives/Hypnotics,Other |
| Nitrous oxide inhalation | Active comparator | Dinitrousoxide (N2O) is given with Livopan administrating device. Livopan consists of 50% oxygen and 50% nitrous oxide. Gas mixture is inhaled 5 minutes before the injection procedure and during the injection procedure. Receives: Drug: Dexmedetomidine; Drug: Sedatives/Hypnotics,Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog scale (VAS)
VAS scores of the pain experienced during the procedure are evaluated as a primary outcome.
Measured: The VAS score is assessed after procedure when the patients have recovered from the sedation and are being discharged. The time of discharge is 1 to 5 hours after the injection procedure.
Secondary outcomes (9)
Blood pressure
Blood pressure is measured indirectly with a cuff
Measured: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
Heart rate
Heart rate is monitored by contiunously assessing Electro Cardiogram
Measured: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
Heart rate
Heart rate is monitored by contiunously assessing pulse oxymetry.
Measured: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
Respiratory rate
Respiratory rate is detected by capnometer or assessed manually
Measured: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
FLACC
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children
Measured: Before the injection procedure, during the injection procedure, 5 and 10 minutes after the procedure and when the patient is being discharged.
COMFORT-B
COMFORT-B is a sedation scale used to assess the level of sedation in children.
Measured: Assessed 20 minutes before the drug administration and in every 15 minutes for six hours after the drug administration and during the injection procedure and 5 and 10 minutes after the injection.
Capnometry
Capnometry detects the exhaled carbon dioxide.
Measured: Assessed continuously 20 minutes before the drug administration and for six hours after the drug administration.
Pulse oxymetry
Oxygen saturation is measured by pulse oxymetry
Measured: Oxygen saturation by pulse oxymetry is measured continuously 20 minutes before the drug administration and for six hours after the drug administration.
Visual Analog scale (VAS)
VAS scores of the pain experienced during the procedure evaluated at the follow up visit.
Measured: At the follow up visit which usually is 2-12 weeks after the injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Feb 2017
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Outi Peltoniemi, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069638
- Sponsor's protocol ID
- INDEXJIA
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2016
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tervonen M, Peltoniemi O, Vahasalo P, Keskitalo P, Sard S, Pokka T, Kallio M. Intranasal dexmedetomidine vs. nitrous oxide for procedural sedation in juvenile idiopathic arthritis (INDEXJIA): a randomized crossover clinical trial. Eur J Pediatr. 2026 Jul 21;185(8):596. doi: 10.1007/s00431-026-07259-w.
PubMed 42479237
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 During Intra-articular Joint Injections in Pediatric Population
- ClinicalTrials.gov ID
- NCT03069638
- Acronym / sponsor ID
- INDEXJIA
- Conditions
- Juvenile Idiopathic Arthritis, Joint Inflammation
- Keywords
- sedation, pediatrics, intranasal sedation, dexmedetomidine, dinitrous oxide, intra-articular joint injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 3 Mar 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.
The main objective of this study is to evaluate the effectivity of intranasal dexmedetomidine sedation during intra-articular injection therapy. Intranasal dexmedetomidine is compared with dinitrous oxide (N2O) which has already been proven safe and effective sedation method during painful procedures in pediatric patients.
In earlier studies the median VAS during intra-articular corticosteroid injections with patients receiving nitrous oxide has been 3 (Uziel et al 2008). Study hypothesis is that with intranasal dexmedetomidine sedation the VAS pain levels will be 1 unit lower.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal dexmedetomidine | Experimental | Drug: Dexmedetomidine, Drug: Sedatives/Hypnotics,OtherDexmedetomidine is given once 4 micrograms per kilogram intranasally. If the sedation is not successful another 2 microgram per kilogram intranasal dose is given. Intravenous dexmedetomidine solution is administrated intranasally with MAD nasal drug delivery device and a syringe. |
| Nitrous oxide inhalation | Active comparator | Drug: Dexmedetomidine, Drug: Sedatives/Hypnotics,OtherDinitrousoxide (N2O) is given with Livopan administrating device. Livopan consists of 50% oxygen and 50% nitrous oxide. Gas mixture is inhaled 5 minutes before the injection procedure and during the injection procedure. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patient age between ages 1year to 18 years
- A joint inflammation in 1-5 joints needing intra-articular corticosteroid injection diagnosed by pediatric rheumatologist
Key exclusion criteria (1 listed)
- Patients under the age of 1year and over the age of 18years are excluded as well as patients needing injection therapy to more than 5 joints.
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 |
|---|---|---|
| DexmedetomidineIntranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection) | Drug | Intranasal dexmedetomidine, Nitrous oxide inhalation |
| Sedatives/Hypnotics,OtherAlso: Dinitrous oxideInhaled dinitrous oxide as procedural sedation (intra-articular joint injection) | Drug | Intranasal dexmedetomidine, Nitrous oxide inhalation |
Primary outcome
Visual Analog scale (VAS)
Time frame: The VAS score is assessed after procedure when the patients have recovered from the sedation and are being discharged. The time of discharge is 1 to 5 hours after the injection procedure.
VAS scores of the pain experienced during the procedure are evaluated as a primary outcome.
9 secondary outcomes
Blood pressure
Time frame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
Heart rate
Time frame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
Heart rate
Time frame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
Respiratory rate
Time frame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
FLACC
Time frame: Before the injection procedure, during the injection procedure, 5 and 10 minutes after the procedure and when the patient is being discharged.
COMFORT-B
Time frame: Assessed 20 minutes before the drug administration and in every 15 minutes for six hours after the drug administration and during the injection procedure and 5 and 10 minutes after the injection.
Capnometry
Time frame: Assessed continuously 20 minutes before the drug administration and for six hours after the drug administration.
Pulse oxymetry
Time frame: Oxygen saturation by pulse oxymetry is measured continuously 20 minutes before the drug administration and for six hours after the drug administration.
Visual Analog scale (VAS)
Time frame: At the follow up visit which usually is 2-12 weeks after the injection.
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 20 Dec 2023.
- Derived from this study: PubMed 42479237Tervonen M, Peltoniemi O, Vahasalo P, Keskitalo P, Sard S, Pokka T, Kallio M. Intranasal dexmedetomidine vs. nitrous oxide for procedural sedation in juvenile idiopathic arthritis (INDEXJIA): a randomized crossover clinical trial. Eur J Pediatr. 2026 Jul 21;185(8):596. doi: 10.1007/s00431-026-07259-w.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Sedatives/Hypnotics,Other in people with Juvenile Idiopathic Arthritis and Joint Inflammation, 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 2 inclusion and 1 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 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. 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?
Visual Analog scale (VAS) (time frame: The VAS score is assessed after procedure when the patients have recovered from the sedation and are being discharged. The time of discharge is 1 to 5 hours after the injection procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03069638, which also lists 1 linked publication.
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.