Clinical trial NCT03564093: Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures
Official title: Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures: Randomized Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain
Anesthesia
Keywords: pediatrics
sedation
emergency room sedation
intranasal sedation
dexmedetomidine
intranasal dexmedetomidine
children
pediatric
pediatric sedation
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 112
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Success of the procedure
timeFrame: After the first attempt of the procedure. The procedure is attempted 30 minutes after the study drug administration.
Secondary outcomes:
measure: The duration of the procedure
timeFrame: 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.
measure: Parents assessment of the patients pain during the procedure
timeFrame: Parents return a questionnaire within 2 hours after the study drug has been administered.
measure: Patient pain VAS
timeFrame: The numerical value of VAS is asked in the end of the follow up period of 2 hours.
measure: Patient pain FLACC
timeFrame: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
measure: Patient sedation level
timeFrame: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
measure: Duration of crying
timeFrame: 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.
measure: Effectivity of the drug
timeFrame: The follow up period lasts 2 hours from the study drug administration.
measure: Blood pressure
timeFrame: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
measure: Respiratory rate
timeFrame: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
measure: Oxygen saturation
timeFrame: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
measure: Heart rate
timeFrame: Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
measure: Attempts needed to complete the procedure
timeFrame: 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.
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Outi Peltoniemi
role: PRINCIPAL_INVESTIGATOR
References: