Intranasal Midazolam for Treatment of Anxiety in Children Undergoing Suturing in the Pediatric Emergency Department

McGill University

Status and phase

Completed

Phase 4

Conditions

Lacerations

Anxiety

Treatments

Drug: Saline

Drug: Midazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT02618772

PED-08-053

Details and patient eligibility

About

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.

Enrollment

79 patients

Sex

All

Ages

2 to 12 years old

Volunteers

Accepts Healthy Volunteers

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