Intranasal dexmedetomidine sedation during intra-articular joint injections in pediatric population

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002065-66-FI

Enrollment

109

Registered

2016-11-02

Start date

2016-11-07

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All the patients from 1year to 18 years of age who have been diagnosed by a pediatric rheumatologist to have a joint inflammation needing intra-articular corticosteroid injection in 1 to 5 joints

Interventions

Trade Name: Dexdor Product Name: Dexdor Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: DEXMEDETOMIDINE CAS Number: 113775-47-6 Trade Name: Livopan Product N

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: -Patients from 1year to 18 years of age -A joint inflammation in 1-5 joints requiring intra-articular corticosteroid injection diagnosed by pediatric rheumatologist Are the trial subjects under 18? yes Number of subjects for this age range: 109 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study is to evaluate the efficacy of intranasal dexmedetomidine sedation during intra-articular injection therapy. We compare intranasal dexmedetomidine with nitrous 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 recieving 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. Nitrous oxide sedation requires spesific equipment for the delivery of the nitrous oxide. Spesific equipment is also needed for the inhalation gas removal. Intranasal dexmedetomidine is given by a syringe via nasal plug that atomizes the drug.;Secondary Objective: We also assess the safety profile and adverse effects of intranasal dexmedetomidine. The efficacy of intranasal dexmedetomidine sedation is assessed by a stratified sedation scale. Cost effectiveness of both treatments is evaluated.;Primary end point(s): The primary end point is the VAS (Visual Analog Scale) pain score during the injection procedure.;Timepoint(s) of evaluation of this end point: The VAS score is evaluated during the procedure and with a questionnaire filled by the patient and parent after the procedure.	—

Measure

Time frame

Main Objective: The main objective of this study is to evaluate the efficacy of intranasal dexmedetomidine sedation during intra-articular injection therapy. We compare intranasal dexmedetomidine with nitrous 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 recieving 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. Nitrous oxide sedation requires spesific equipment for the delivery of the nitrous oxide. Spesific equipment is also needed for the inhalation gas removal. Intranasal dexmedetomidine is given by a syringe via nasal plug that atomizes the drug.;Secondary Objective: We also assess the safety profile and adverse effects of intranasal dexmedetomidine. The efficacy of intranasal dexmedetomidine sedation is assessed by a stratified sedation scale. Cost effectiveness of both treatments is evaluated.;Primary end point(s): The primary end point is the VAS (Visual Analog Scale) pain score during the injection procedure.;Timepoint(s) of evaluation of this end point: The VAS score is evaluated during the procedure and with a questionnaire filled by the patient and parent after the procedure.

—

Secondary

Measure	Time frame
Secondary end point(s): Patients sedation level is evaluated with stratified sedation scales. Blood pressure, heart rate, respiratory rate and oxygen saturation are monitored during the procedure. Capnography readings are measured to identify possible events of apnea. All the adverse effects are noted and treated if necessary by the health care staff. Costs of the sedation protocols are evaluated. ;Timepoint(s) of evaluation of this end point: Secondary outcomes are evaluated during the procedure and afterwards with a questionnaire.	—

Measure

Time frame

Secondary end point(s): Patients sedation level is evaluated with stratified sedation scales. Blood pressure, heart rate, respiratory rate and oxygen saturation are monitored during the procedure. Capnography readings are measured to identify possible events of apnea. All the adverse effects are noted and treated if necessary by the health care staff. Costs of the sedation protocols are evaluated. ;Timepoint(s) of evaluation of this end point: Secondary outcomes are evaluated during the procedure and afterwards with a questionnaire.

—

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026