Intranasal Midazolam for Treatment of Anxiety in Children Undergoing Suturing in the Pediatric Emergency Department
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
McGill University Health Center McGill University Health Centre/Research Institute of the McGill University Health Centre