Intranasal Midazolam for Treatment of Anxiety in Children Undergoing Suturing in the Pediatric Emergency Department
Condition: Anxiety; Lacerations
MeSH terms: Emergencies; Lacerations; Anxiety Disorders
Intervention: Midazolam; Saline
Intervention description: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair; Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo
Intervention MeSH terms: Midazolam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 2 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pediatrics; Laceration; Anxiety; Anti-Anxiety Agents

Summary:

      Laceration repair can cause significant anxiety in children. As open wounds account for
      21-25% of injuries in children presenting to the emergency department, the management of
      anxiety is of great importance. Anxiety can often lead to poor patient cooperation and the
      use of potentially excessive physical restraint. High rates of procedural anxiety have also
      been correlated with increased rates of negative behaviours after discharge.

      The current standard of care for suture closure of lacerations throughout most of Canada is
      to provide local analgesia only. The literature has therefore focused on finding anxiolytic
      adjuncts to local analgesia.

      Midazolam is an ideal adjunct due to its fast onset and short duration of action with an
      excellent safety profile. The advantages of the IN route are less pain on administration when
      compared to the IV and IM routes, and increased acceptability compared to the rectal route in
      older children. Oral midazolam also has poor palatability.

      While the onset of INM at 5-10 minutes, and duration of 20-40 minutes make it an ideal
      candidate for anxiolysis in the ED its use has been limited by the common side effect of
      nasal irritation, burning and lacrimation when it is administered in its droplet form. The
      recent development of mucosal atomization devices (MAD) has resolved this issue by delivering
      30-μ particles to the nasal mucosa.

      Previous studies investigating the use of INM for laceration repair in the pediatric ED have
      demonstrated that INM is safe but most used non-validated measurement tools to assess anxiety
      and facilitation. Only one of these studies used atomized INM, retrospectively examining
      safety as the primary outcome. The authors reported an excellent safety profile for INM using
      the mucosal atomization device MAD-300 (Wolfe Tory Medical Inc.). The use of atomized INM for
      anxiolysis during pediatric laceration repair has not been evaluated prospectively.

      Most studies have focused on preschool aged children (<6 years). While studies have
      demonstrated that the prevalence of procedural anxiety is higher in younger children, up to
      51% of children age 7-12 years experience high levels of procedural distress. The
      effectiveness of INM in the pre-adolescent age group is, therefore, yet to be determined.

      It is hypothesized that INM will reduce anxiety in children age 2-12 years undergoing
      laceration repair and will facilitate the successful completion of suturing by the physician.
    

Eligibility criteria:

        Inclusion Criteria:

          -  children 2-12 years requiring laceration repair using suturing and use of injected
             lidocaine

        Exclusion Criteria:

          -  Administration in ER of analgesia or sedation other than acetaminophen or ibuprofen
             prior to enrolment

          -  ASA of III or greater

          -  Multi-system trauma

          -  Severe neurologic impairment or non-verbal autism, known allergy/hypersensitivity to
             lidocaine or midazolam

          -  Parent/guardian does not speak one of French or English

          -  No parent/guardian present during procedure