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

NCT02618772 | Completed Phase 4 Results DMC

• 1 other identifier: PED-08-053
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety; Lacerations

Keywords

Pediatrics; Laceration; Anxiety; Anti-Anxiety Agents

Outcome Measures

Primary Outcomes (2)

• Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)

  Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the "suturing" by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety. The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety.

  Day 1: During suturing

• Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)

  Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the "suturing" by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety. The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety.

  Day 1: During suturing

Secondary Outcomes (8)

• Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)

  Day 1: During Baseline, Intervention & Lidocaine

• Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)

  Day 1: Baseline, Intervention & Lidocaine

• Intention to Treat (ITT): State Trait Anxiety Inventory (STAI)

  Day 1: Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day)

• Per-Protocol: State Trait Anxiety Inventory (STAI)

  Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day)

• Intention to Treat (ITT): Dartmouth Operative Conditions Scale

  Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day)

Other Outcomes (4)

• Time That the Participant Remained in Hospital After Procedure (Mins)

  Day 1: at discharge from emergency department (i.e. same day)

• Length of Procedure (Mins)

  Day 1

• Physician's Prediction is Respect to Intervention Drug

  Day 1: physician asked immediately after procedure finished

Study Arms (2)

Intranasal Saline

PLACEBO COMPARATOR

0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300

Drug: Saline

Intranasal Midazolam

ACTIVE COMPARATOR

0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300

Drug: Midazolam

Interventions

Midazolam DRUG

Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair

Intranasal Midazolam

Saline DRUG

Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo

Intranasal Saline

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children 2-12 years requiring laceration repair using suturing and use of injected lidocaine

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

MeSH Terms

Conditions

Anxiety Disorders; Lacerations

Interventions

Midazolam; Sodium Chloride

Condition Hierarchy (Ancestors)

Mental Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Jennifer Turnbull
• Organization: MUHC

jennifer.turnbull@mcgill.ca

514-412-4400

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jennifer Turnbull, MD, FRCPC

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 1, 2015
• Study Start: January 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 7, 2016
• Results First Posted: October 7, 2016

Record last verified: 2016-09