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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02618772
Other study ID # PED-08-053
Secondary ID
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


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
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