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

• Register: EUCTR
• Last refreshed on: 14 November 2016
• Main ID: EUCTR2016-002065-66-FI
• Date of registration: 02/11/2016
• Prospective Registration: Yes
• Primary sponsor: Miikka Tervonen
• Public title: Intranasal dexmedetomidine sedation during intra-articular joint injections in pediatric population
• Scientific title: Intranasal dexmedetomidine sedation during intra-articular joint injections in pediatric population
• Date of first enrolment: 07/11/2016
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002065-66
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Finland

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Intervention(s)

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 Name: Livopan
Pharmaceutical Form: Medicinal gas, compressed
CAS Number: 10024-97-2
Other descriptive name: NITROUS OXIDE
INN or Proposed INN: OXYGEN

Primary Outcome(s)

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.

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.

Primary end point(s): The primary end point is the VAS (Visual Analog Scale) pain score during
the injection procedure.

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 Outcome(s)

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.

Secondary ID(s)

OY102016