Clinical trial NCT02618772: Intranasal Midazolam for Treatment of Anxiety in Children Undergoing Suturing in the Pediatric Emergency Department
Official title: Atomized Intranasal Midazolam for Anxiolysis and Facilitation of Laceration Repair in the Pediatric Emergency Department: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anxiety
Lacerations
Keywords: Pediatrics
Laceration
Anxiety
Anti-Anxiety Agents
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 79
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)
timeFrame: Day 1: During suturing
measure: Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)
timeFrame: Day 1: During suturing
Secondary outcomes:
measure: Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)
timeFrame: Day 1: During Baseline, Intervention & Lidocaine
measure: Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)
timeFrame: Day 1: Baseline, Intervention & Lidocaine
measure: Intention to Treat (ITT): State Trait Anxiety Inventory (STAI)
timeFrame: Day 1: Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day)
measure: Per-Protocol: State Trait Anxiety Inventory (STAI)
timeFrame: Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day)
measure: Intention to Treat (ITT): Dartmouth Operative Conditions Scale
timeFrame: Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day)
measure: Per-Protocol: Dartmouth Operative Conditions Scale
timeFrame: Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day)
measure: Intention to Treat (ITT): Faces Pain Scale-Revised/ FLACC Scale
timeFrame: Day 1: immediately after intervention
measure: Per-Protocol: Faces Pain Scale-Revised/ FLACC Scale
timeFrame: Day 1: immediately after intervention
Other outcomes:
measure: Time That the Participant Remained in Hospital After Procedure (Mins)
timeFrame: Day 1: at discharge from emergency department (i.e. same day)
measure: Length of Procedure (Mins)
timeFrame: Day 1
measure: Physician's Prediction is Respect to Intervention Drug
timeFrame: Day 1: physician asked immediately after procedure finished
measure: Guardian/Parent's Prediction is Respect to Intervention Drug
timeFrame: Day 1: parent asked immediately after procedure complete
Locations:
Study officials:
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