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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Saline | Placebo Comparator | 0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time That the Participant Remained in Hospital After Procedure (Mins) | Length of stay in the emergency department, measured from the end of the procedure to the time of discharge. | Day 1: at discharge from emergency department (i.e. same day) |
| Length of Procedure (Mins) |
Inclusion Criteria:
Exclusion Criteria:
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Recruitment began on January 13, 2010 and was completed on March 17, 2015. Recruitment took place solely in the Pediatric Emergency Department at the Montreal Children's Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intranasal Saline | 0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300 Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair |
| FG001 | Intranasal Midazolam | 0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300 Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study Population: Children 2-12 years old who presented to the Montreal Children's Hospital Emergency Department with a laceration requiring repair with sutures under local analgesia (local injection of lidocaine).
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| ID | Title | Description |
|---|---|---|
| BG000 | Intranasal Saline | 0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300 Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair |
| BG001 | Intranasal Midazolam |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. | Posted | Mean | Standard Deviation | units on a scale | Day 1: During suturing |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intranasal Saline | 0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300 Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| oxygen saturation less than 92% | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Not requiring intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Turnbull | MUHC | 514-412-4400 | 23039 | jennifer.turnbull@mcgill.ca |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Saline | Drug | Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo |
|
| Day 1: During Baseline, Intervention & Lidocaine |
| 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: Baseline, Intervention & Lidocaine |
| Intention to Treat (ITT): State Trait Anxiety Inventory (STAI) | 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. | 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) | 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. | 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 | 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. | Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day) |
| Per-Protocol: Dartmouth Operative Conditions Scale | 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. | Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day) |
| Intention to Treat (ITT): Faces Pain Scale-Revised/ FLACC Scale | 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). | Day 1: immediately after intervention |
| Per-Protocol: Faces Pain Scale-Revised/ FLACC Scale | 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). | Day 1: immediately after intervention |
This is a measure of the length of the procedure (suturing) in minutes. |
| Day 1 |
| Physician's Prediction is Respect to Intervention Drug | 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. | Day 1: physician asked immediately after procedure finished |
| Guardian/Parent's Prediction is Respect to Intervention Drug | 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. | Day 1: parent asked immediately after procedure complete |
0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300 Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Number | participants |
|
| Region of Enrollment | All participants were enrolled at the Montreal Children's Hospital in Montreal, Quebec (Canada). The address is as follows: 2300 Tupper, Montreal (QC), Canada, H3H 1P3. | Number | Participants |
|
| Laceration Length (cm) | This baseline measure describes the length of the participant's laceration (centimeters) at the time of recruitment. This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Mean | Standard Deviation | Centimeters (cm) |
|
| Laceration Location: Above Neck | This baseline measure describes the number of participants whose laceration was located above the neck i.e., either on the participant's neck or head. This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Number | Participants |
|
| Laceration Location: Below Neck | This baseline measure describes the number of participants whose laceration was located above the neck i.e., either on the participant's neck or head. This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Number | Participants |
|
| Weight (kg) | This baseline measure describes weight of the participants in kilograms. This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Mean | Standard Deviation | Kilograms (kg) |
|
| Triage Vitals: Heart Rate | This baseline measure describes the heart rate of participants at triage. Heart rate is measured by the number of contractions of the heart per minute (bpm). Note: not all participants had their heart rate measured at triage. This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Mean | Standard Deviation | Beats per Minute (bpm) |
|
| Triage Vitals: Blood Pressure (Systolic) | This baseline measure describes the blood pressure (systolic) at triage measured in millimeters of mercury (mm Hg). Note: not all participants had their blood pressure (systolic) measured at triage. This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Mean | Standard Deviation | mm Hg |
|
| Triage Vitals: Blood Pressure (Diastolic) | This baseline measure describes the blood pressure (diastolic) at triage measured in millimeters of mercury (mm Hg). Note: not all participants had their blood pressure (diastolic) measured at triage. This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Mean | Standard Deviation | mm Hg |
|
| Triage Vitals: Oxygen Saturation | This baseline measure describes the oxygen saturation at triage measured in percent (%). Note: not all participants had their oxygen saturation measured at triage. This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Mean | Standard Deviation | Percent (%) |
|
| Nasal Congestion | This baseline characteristic is a measure of the number of participants who experienced nasal congestion at the time of recruitment. This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Number | Participants |
|
| LET: Lidocaine, Epinephrine and Tetracaine Gel Use | LET is a combination of lidocaine (4 percent), epinephrine (0.1 percent), and tetracaine (0.5 percent) available for use as a topical anesthetic. This baseline variable describes participants who had LET applied to their wounds prior to sutures. This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Intranasal Saline | 0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300 Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair |
| OG001 | Intranasal Midazolam | 0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300 Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair |
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| Primary | 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. | This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Posted | Mean | Standard Deviation | units on a scale | Day 1: During suturing |
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| Secondary | 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. | This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. | Posted | Mean | Standard Deviation | units on a scale | Day 1: During Baseline, Intervention & Lidocaine |
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| Secondary | 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. | This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Posted | Mean | Standard Deviation | units on a scale | Day 1: Baseline, Intervention & Lidocaine |
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| Secondary | Intention to Treat (ITT): State Trait Anxiety Inventory (STAI) | 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. | This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. | Posted | Mean | Standard Deviation | units on a scale | Day 1: Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day) |
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| Secondary | Per-Protocol: State Trait Anxiety Inventory (STAI) | 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. | This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Posted | Mean | Standard Deviation | units on a scale | Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day) |
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| Secondary | Intention to Treat (ITT): Dartmouth Operative Conditions Scale | 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. | This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. | Posted | Mean | Standard Deviation | units on a scale | Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day) |
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| Secondary | Per-Protocol: Dartmouth Operative Conditions Scale | 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. | This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Posted | Mean | Standard Deviation | units on a scale | Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day) |
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| Secondary | Intention to Treat (ITT): Faces Pain Scale-Revised/ FLACC Scale | 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). | This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam. | Posted | Mean | Standard Deviation | units on a scale | Day 1: immediately after intervention |
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| Secondary | Per-Protocol: Faces Pain Scale-Revised/ FLACC Scale | 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). | This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment. | Posted | Mean | Standard Deviation | units on a scale | Day 1: immediately after intervention |
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| Other Pre-specified | Time That the Participant Remained in Hospital After Procedure (Mins) | Length of stay in the emergency department, measured from the end of the procedure to the time of discharge. | Posted | Mean | Standard Deviation | minutes | Day 1: at discharge from emergency department (i.e. same day) |
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| Other Pre-specified | Length of Procedure (Mins) | This is a measure of the length of the procedure (suturing) in minutes. | Posted | Mean | Standard Deviation | minutes | Day 1 |
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| Other Pre-specified | Physician's Prediction is Respect to Intervention Drug | 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. | Posted | Number | Times correct | Day 1: physician asked immediately after procedure finished |
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| Other Pre-specified | Guardian/Parent's Prediction is Respect to Intervention Drug | 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. | Posted | Number | Times correct | Day 1: parent asked immediately after procedure complete |
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| 0 |
| 39 |
| 2 |
| 39 |
| EG001 | Intranasal Midazolam | 0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300 Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair | 0 | 40 | 1 | 40 |
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Not provided
Not provided
Not provided
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Lidocaine (n = 34, 36) |
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| Suturing Minus Baseline (n = 33, 38)) |
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This is in reference to the intervention measure. |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.198 | This is in reference to the lidocaine measure. | No | Superiority or Other |
| t-test, 2 sided | 0.006 | This is in reference to the difference between the suturing and baseline measures. | No | Superiority or Other |
| Lidocaine (n = 34, 35) |
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| Suturing Minus Baseline (n = 32, 36) |
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This is in reference to the intervention measure. |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.191 | This is in reference to the lidocaine measure. | No | Superiority or Other |
| t-test, 2 sided | 0.008 | This is in reference to the difference between the suturing and baseline measures. | No | Superiority or Other |
| STAI Post Minus Pre (n = 35, 37) |
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| STAI Post Minus Pre (n = 32, 34) |
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