Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures
Condition: Dexmedetomidine; Sedation
Study type: Observational

Summary: 
      Specific Aim 1: To describe the adequacy of sedation associated with different regimens of IN
      DEX in children undergoing non-painful procedures. This aim will test the working hypothesis
      that IN DEX regimens are effective for producing sedation adequate for completion of
      non-painful procedures in children.

      Specific Aim 2: To describe the temporal characteristics associated with varied regimens of
      IN DEX in children undergoing non-painful procedures, such as time to onset of adequate
      sedation; time to procedure start; and time from procedure end to meeting discharge criteria.
      This aim will test the working hypothesis that IN DEX regimens have temporal characteristics
      that are favourable for sedating children for non-painful procedures.

      Specific Aim 3: To describe the adverse events associated with varied regimens of IN DEX in
      children undergoing non-painful procedures. This aim will test the working hypothesis that IN
      DEX regimens have a low incidence of adverse events.
    

Detailed description: 
      Dexmedetomidine (DEX) is an alpha-2 receptor agonist with sedative, anxiolytic, and
      analgesics properties. DEX has been used extensively for sedation in children to facilitate
      different non-painful procedures, such magnetic resonance imaging (MRI), auditory brainstem
      response (ABR) tests, and computed tomography (CT) scans. In particular, DEX can be
      administered by the intranasal (IN) route. Intranasal administration has the benefits of
      being both effective and needle-free, of which the latter makes it less distressing to
      children compared to sedatives administered by the intravenous (IV) route. There is a gap of
      knowledge, however, regarding the ideal regimen of IN DEX for providing optimal procedural
      sedation in children undergoing non-painful procedures. There is a large variation in
      practice using IN DEX, both regarding the dose and the use of adjunct medications. It is also
      unknown whether regimens should vary based on patient factors such as age. There is no clear
      evidence to define best practice when using IN DEX to provide sedation in this population to
      achieve the desired outcomes most relevant to clinicians. The rationale of the proposed
      investigation is that by conducting an exploratory study to measure clinical outcomes
      associated with IN DEX, the investigators can begin to identify trends and differences that
      will lay the foundation for randomized clinical trials to identify the ideal regimen for IN
      DEX when providing sedation for non-painful procedures. This will then allow the
      investigators to compare IN DEX, at its best, to other sedatives so that the sedative and
      regimen associated with the best outcomes relevant to sedation of children undergoing
      non-painful procedures can be determined.
    

Intervention name(s): Intranasal dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Intranasal dexemedetomidine (100 mcg/mL), 0.5 to 4 mcg/kg
Intervention MeSH terms: Dexmedetomidine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children undergoing sedation using intranasal dexmedetomidine for non-painful procedures.
      
Keywords: Dexmedetomidine; Sedation; Pediatric