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

Anxiety Clinical Trial

Official title:

Atomized Intranasal Midazolam for Anxiolysis and Facilitation of Laceration Repair in the Pediatric Emergency Department: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618772
• Other study ID #: PED-08-053
• Status: Completed
• Phase: Phase 4
• First received: November 23, 2015
• Last updated: November 28, 2015
• Start date: January 2010
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: November 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Lacerations

Intervention

Drug:
• Midazolam
Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair
• Saline
Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of stay	Length of stay in the emergency department, measured from the time of intervention to discharge	Day 1: at discharge from emergency department (i.e. same day)	No
Primary	modified Yale Preoperative Anxiety Score	measurement of patient anxiety used to test effect of anxiolytic pre-medication	Day 1: During suturing	No
Secondary	State Trait Anxiety Inventory	Validated measurement of anxiety, to be used to test parental/guardian anxiety at 2 time points	Day 1: Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day)	No
Secondary	Dartmouth Operative Conditions Scale	A tool to measure the effectiveness and safety of sedation	Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day)	Yes
Secondary	Faces Pain Scale-revised	Validated self-report tool of pain	Day 1: immediately after intervention	No
Secondary	FLACC Scale	Tool to assess pain in children unable to use Faces Pain Scale-revised	Day 1: immediately after intervention	No