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Completed

NCT Number: NCT02618772

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

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.

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Key information

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

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

Saline

Drug

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

Primary outcomes

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

    Time frame: Day 1: During suturing

    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.

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

    Time frame: Day 1: During suturing

    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.

Secondary outcomes

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

    Time frame: Day 1: During Baseline, Intervention & Lidocaine

    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.

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

    Time frame: Day 1: Baseline, Intervention & Lidocaine

    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.

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

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

    Validated measurement of anxiety, to be used to test parental/guardian anxiety at two time points. These time points are before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day). The STAI contains 10 items for assessing trait anxiety and 10 for state anxiety. All items are rated on a standard scale ("Not at all", "Somewhat", "Moderately so", "Very much so") with a range of 20 to 80 where higher scores indicate greater anxiety and lower scores indicate lower levels of anxiety.

  4. Per-Protocol: State Trait Anxiety Inventory (STAI)

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

    Validated measurement of anxiety, to be used to test parental/guardian anxiety at two time points. These time points are before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day). The STAI contains 10 items for assessing trait anxiety and 10 for state anxiety. All items are rated on a standard scale ("Not at all", "Somewhat", "Moderately so", "Very much so") with a range of 20 to 80 where higher scores indicate greater anxiety and lower scores indicate lower levels of anxiety.

  5. Intention to Treat (ITT): Dartmouth Operative Conditions Scale

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

    A tool to measure the effectiveness and safety of pediatric sedation, regardless of technique used for decreasing anxiety or pain during a procedure. The scale asks the physician to rate patient states (pain/stress, movement, consciousness & sedation side effects) based on observed behaviors (each observed behavior is given a score). The scores are then added together to give a score where -3 to 5 where the lower number is indicative of less anxiety/pain.

  6. Per-Protocol: Dartmouth Operative Conditions Scale

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

    A tool to measure the effectiveness and safety of pediatric sedation, regardless of technique used for decreasing anxiety or pain during a procedure. The scale asks the physician to rate patient states (pain/stress, movement, consciousness & sedation side effects) based on observed behaviors (each observed behavior is given a score). The scores are then added together to give a score where -3 to 5 where the lower number is indicative of less anxiety/pain.

  7. Intention to Treat (ITT): Faces Pain Scale-Revised/ FLACC Scale

    Time frame: Day 1: immediately after intervention

    Faces Pain Scale: Validated self-report tool of pain for participants less than 5 years old. It is a scale that allows one to score the sensation of pain from zero to ten. The scale shows a visuals (faces) for each levels 0, 2, 4, 6, 8 and 10 of the scale. For example, 0 is represented by a "face" visual that expresses no hurt.

    FLACC Scale: Tool to assess pain in children unable to use Faces Pain Scale-revised. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 (0 represents no pain).

  8. Per-Protocol: Faces Pain Scale-Revised/ FLACC Scale

    Time frame: Day 1: immediately after intervention

    Faces Pain Scale: Validated self-report tool of pain for participants less than 5 years old. It is a scale that allows one to score the sensation of pain from zero to ten. The scale shows a visuals (faces) for each levels 0, 2, 4, 6, 8 and 10 of the scale. For example, 0 is represented by a "face" visual that expresses no hurt.

    FLACC Scale: Tool to assess pain in children unable to use Faces Pain Scale-revised. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 (0 represents no pain).

Other outcomes

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

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

    Length of stay in the emergency department, measured from the end of the procedure to the time of discharge.

  2. Length of Procedure (Mins)

    Time frame: Day 1

    This is a measure of the length of the procedure (suturing) in minutes.

  3. Physician's Prediction is Respect to Intervention Drug

    Time frame: Day 1: physician asked immediately after procedure finished

    This is a measure how how many times the physician was correct in predicting whether the patient received intranasal saline or intranasal midazolam as the intervention drug.

  4. Guardian/Parent's Prediction is Respect to Intervention Drug

    Time frame: Day 1: parent asked immediately after procedure complete

    This is a measure how how many times the parent/guardian was correct in predicting whether the patient received intranasal saline or intranasal midazolam as the intervention drug.

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Dec 1, 2015
Registry last updated
Oct 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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