Anxiety, Lacerations
Conditions
Keywords
Pediatrics, Laceration, Anxiety, Anti-Anxiety Agents
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.
Interventions
DRUGMidazolam
Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair
DRUGSaline
Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS) | 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. |
| Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Per-Protocol: State Trait Anxiety Inventory (STAI) | 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. |
| Intention to Treat (ITT): Dartmouth Operative Conditions Scale | 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. |
| Per-Protocol: Dartmouth Operative Conditions Scale | 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. |
| Intention to Treat (ITT): Faces Pain Scale-Revised/ FLACC Scale | 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). |
| Per-Protocol: Faces Pain Scale-Revised/ FLACC Scale | 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). |
| Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS) | 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. |
| Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS) | 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. |
| 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) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Guardian/Parent's Prediction is Respect to Intervention Drug | 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. |
| Physician's Prediction is Respect to Intervention Drug | 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. |
| Length of Procedure (Mins) | Day 1 | This is a measure of the length of the procedure (suturing) in minutes. |
| Time That the Participant Remained in Hospital After Procedure (Mins) | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 39 |
| 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 | 40 |
| Total | 79 |
Baseline characteristics
| Characteristic | Intranasal Midazolam | Intranasal Saline | Total |
|---|---|---|---|
| Age, Customized Intention to Treat (ITT): (n = 39, 40, 79) | 6.8642 years STANDARD_DEVIATION 3.5191 | 7.3554 years STANDARD_DEVIATION 3.2152 | 7.1067 years STANDARD_DEVIATION 3.35997 |
| Age, Customized Per-Protocol (PP): (n = 35, 37, 72) | 6.8454 years STANDARD_DEVIATION 3.6318 | 7.3848 years STANDARD_DEVIATION 3.1826 | 7.1076 years STANDARD_DEVIATION 3.4077 |
| Laceration Length (cm) Intention to Treat (ITT): (n = 39, 38, 77) | 2.995 Centimeters (cm) STANDARD_DEVIATION 2.9506 | 2.395 Centimeters (cm) STANDARD_DEVIATION 2.2319 | 2.691 Centimeters (cm) STANDARD_DEVIATION 2.6116 |
| Laceration Length (cm) Per-Protocol (PP): (n = 35, 36, 71) | 3.056 Centimeters (cm) STANDARD_DEVIATION 3.0184 | 2.389 Centimeters (cm) STANDARD_DEVIATION 2.3241 | 2.727 Centimeters (cm) STANDARD_DEVIATION 2.7003 |
| Laceration Location: Above Neck Intention to Treat (ITT) | 18 Participants | 25 Participants | 43 Participants |
| Laceration Location: Above Neck Per-Protocol (PP) | 16 Participants | 22 Participants | 38 Participants |
| Laceration Location: Below Neck Intention to Treat (ITT) | 22 Participants | 14 Participants | 36 Participants |
| Laceration Location: Below Neck Per-Protocol (PP) | 21 Participants | 13 Participants | 34 Participants |
| LET: Lidocaine, Epinephrine and Tetracaine Gel Use Intention to Treat (ITT) | 26 participants | 24 participants | 50 participants |
| LET: Lidocaine, Epinephrine and Tetracaine Gel Use Per-Protocol (PP) | 24 participants | 21 participants | 45 participants |
| Nasal Congestion Intention to Treat (ITT) | 9 Participants | 5 Participants | 14 Participants |
| Nasal Congestion Per-Protocol (PP) | 9 Participants | 4 Participants | 13 Participants |
| Region of Enrollment Canada | 40 Participants | 39 Participants | 79 Participants |
| Sex/Gender, Customized Intention to Treat (ITT): Female | 15 participants | 10 participants | 25 participants |
| Sex/Gender, Customized Intention to Treat (ITT): Male | 25 participants | 29 participants | 54 participants |
| Sex/Gender, Customized Per-Protocol (PP): Female | 15 participants | 9 participants | 24 participants |
| Sex/Gender, Customized Per-Protocol (PP): Male | 22 participants | 26 participants | 48 participants |
| Triage Vitals: Blood Pressure (Diastolic) Intention to Treat (ITT): (n = 10, 9, 19) | 73.22 mm Hg STANDARD_DEVIATION 7.759 | 66.00 mm Hg STANDARD_DEVIATION 12.702 | 69.42 mm Hg STANDARD_DEVIATION 11.007 |
| Triage Vitals: Blood Pressure (Diastolic) Per-Protocol (PP): (n = 10, 9, 19) | 73.22 mm Hg STANDARD_DEVIATION 7.759 | 66.00 mm Hg STANDARD_DEVIATION 12.702 | 69.42 mm Hg STANDARD_DEVIATION 11.007 |
| Triage Vitals: Blood Pressure (Systolic) Intention to Treat (ITT): (n = 10, 9, 19) | 115.56 mm Hg STANDARD_DEVIATION 15.915 | 110.9 mm Hg STANDARD_DEVIATION 10.826 | 113.11 mm Hg STANDARD_DEVIATION 13.3 |
| Triage Vitals: Blood Pressure (Systolic) Per-Protocol (PP): (n = 10, 9, 19) | 115.56 mm Hg STANDARD_DEVIATION 15.915 | 110.9 mm Hg STANDARD_DEVIATION 10.826 | 113.11 mm Hg STANDARD_DEVIATION 13.3 |
| Triage Vitals: Heart Rate Intention to Treat (ITT): (n = 13, 14, 27) | 102.71 Beats per Minute (bpm) STANDARD_DEVIATION 13.088 | 96.54 Beats per Minute (bpm) STANDARD_DEVIATION 15.613 | 99.74 Beats per Minute (bpm) STANDARD_DEVIATION 14.42 |
| Triage Vitals: Heart Rate Per-Protocol (PP): (n = 13, 13, 26) | 102.00 Beats per Minute (bpm) STANDARD_DEVIATION 13.335 | 96.54 Beats per Minute (bpm) STANDARD_DEVIATION 15.613 | 99.27 Beats per Minute (bpm) STANDARD_DEVIATION 14.496 |
| Triage Vitals: Oxygen Saturation Intention to Treat (ITT): (n = 9, 9, 18) | 99.22 Percent (%) STANDARD_DEVIATION 1.394 | 99.00 Percent (%) STANDARD_DEVIATION 1.658 | 99.11 Percent (%) STANDARD_DEVIATION 1.491 |
| Triage Vitals: Oxygen Saturation Per-Protocol (PP): (n = 9, 8, 17) | 99.13 Percent (%) STANDARD_DEVIATION 1.458 | 99.00 Percent (%) STANDARD_DEVIATION 1.658 | 99.06 Percent (%) STANDARD_DEVIATION 1.519 |
| Weight (kg) Intention to Treat (ITT): (n = 39, 40, 79) | 27.67 Kilograms (kg) STANDARD_DEVIATION 17.348 | 27.63 Kilograms (kg) STANDARD_DEVIATION 10.271 | 27.65 Kilograms (kg) STANDARD_DEVIATION 14.208 |
| Weight (kg) Per-Protocol (PP): (n = 35, 37, 72) | 28.02 Kilograms (kg) STANDARD_DEVIATION 18.002 | 27.41 Kilograms (kg) STANDARD_DEVIATION 10.315 | 27.72 Kilograms (kg) STANDARD_DEVIATION 14.675 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 39 | 1 / 40 |
| serious Total, serious adverse events | 0 / 39 | 0 / 40 |
Outcome results
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.
Time frame: Day 1: During suturing
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Saline | Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS) | 59.9201 units on a scale | Standard Deviation 30.2724 |
| Intranasal Midazolam | Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS) | 46.2871 units on a scale | Standard Deviation 20.5941 |
p-value: 0.026t-test, 2 sided
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.
Time frame: Day 1: During suturing
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Saline | Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS) | 58.7056 units on a scale | Standard Deviation 29.8887 |
| Intranasal Midazolam | Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS) | 45.4633 units on a scale | Standard Deviation 21.20793 |
p-value: 0.036t-test, 2 sided
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.
Time frame: Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Saline | Intention to Treat (ITT): Dartmouth Operative Conditions Scale | 1.92 units on a scale | Standard Deviation 1.949 |
| Intranasal Midazolam | Intention to Treat (ITT): Dartmouth Operative Conditions Scale | 1.15 units on a scale | Standard Deviation 1.847 |
p-value: 0.08t-test, 2 sided
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).
Time frame: Day 1: immediately after intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Saline | Intention to Treat (ITT): Faces Pain Scale-Revised/ FLACC Scale | 2.61 units on a scale | Standard Deviation 2.605 |
| Intranasal Midazolam | Intention to Treat (ITT): Faces Pain Scale-Revised/ FLACC Scale | 5.25 units on a scale | Standard Deviation 2.898 |
p-value: <0.05t-test, 2 sided
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.
Time frame: Day 1: During Baseline, Intervention & Lidocaine
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Saline | Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS) | Baseline (n = 35, 38) | 29.9257 units on a scale | Standard Deviation 8.5783 |
| Intranasal Saline | Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS) | Intervention (n = 32, 38) | 45.1373 units on a scale | Standard Deviation 20.9071 |
| Intranasal Saline | Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS) | Lidocaine (n = 34, 36) | 68.8275 units on a scale | Standard Deviation 26.1481 |
| Intranasal Saline | Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS) | Suturing Minus Baseline (n = 33, 38)) | 30.3485 units on a scale | Standard Deviation 31.0004 |
| Intranasal Midazolam | Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS) | Suturing Minus Baseline (n = 33, 38)) | 13.2166 units on a scale | Standard Deviation 18.719 |
| Intranasal Midazolam | Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS) | Baseline (n = 35, 38) | 32.9461 units on a scale | Standard Deviation 9.137 |
| Intranasal Midazolam | Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS) | Lidocaine (n = 34, 36) | 61.1871 units on a scale | Standard Deviation 22.9957 |
| Intranasal Midazolam | Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS) | Intervention (n = 32, 38) | 58.5803 units on a scale | Standard Deviation 25.6165 |
p-value: 0.151t-test, 2 sided
p-value: 0.02t-test, 2 sided
p-value: 0.198t-test, 2 sided
p-value: 0.006t-test, 2 sided
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.
Time frame: Day 1: Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Saline | Intention to Treat (ITT): State Trait Anxiety Inventory (STAI) | STAI Pre (n = 36, 37) | 39.3333 units on a scale | Standard Deviation 11.1867 |
| Intranasal Saline | Intention to Treat (ITT): State Trait Anxiety Inventory (STAI) | STAI Post (n = 37, 40) | 38.3784 units on a scale | Standard Deviation 12.7788 |
| Intranasal Saline | Intention to Treat (ITT): State Trait Anxiety Inventory (STAI) | STAI Post Minus Pre (n = 35, 37) | -0.5143 units on a scale | Standard Deviation 8.8993 |
| Intranasal Midazolam | Intention to Treat (ITT): State Trait Anxiety Inventory (STAI) | STAI Pre (n = 36, 37) | 43.1351 units on a scale | Standard Deviation 14.6461 |
| Intranasal Midazolam | Intention to Treat (ITT): State Trait Anxiety Inventory (STAI) | STAI Post (n = 37, 40) | 34.5500 units on a scale | Standard Deviation 11.2682 |
| Intranasal Midazolam | Intention to Treat (ITT): State Trait Anxiety Inventory (STAI) | STAI Post Minus Pre (n = 35, 37) | -8.2162 units on a scale | Standard Deviation 12.4992 |
p-value: 0.004t-test, 2 sided
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.
Time frame: Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Saline | Per-Protocol: Dartmouth Operative Conditions Scale | 1.88 units on a scale | Standard Deviation 1.966 |
| Intranasal Midazolam | Per-Protocol: Dartmouth Operative Conditions Scale | 1.08 units on a scale | Standard Deviation 1.906 |
p-value: 0.086t-test, 2 sided
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).
Time frame: Day 1: immediately after intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Saline | Per-Protocol: Faces Pain Scale-Revised/ FLACC Scale | 2.47 units on a scale | Standard Deviation 2.608 |
| Intranasal Midazolam | Per-Protocol: Faces Pain Scale-Revised/ FLACC Scale | 5.19 units on a scale | Standard Deviation 2.895 |
p-value: <0.05t-test, 2 sided
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.
Time frame: Day 1: Baseline, Intervention & Lidocaine
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Saline | Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS) | Intervention (n = 30, 36) | 43.0638 units on a scale | Standard Deviation 19.5711 |
| Intranasal Saline | Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS) | Baseline (n = 33, 36) | 30.0318 units on a scale | Standard Deviation 8.8073 |
| Intranasal Saline | Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS) | Lidocaine (n = 34, 35) | 68.8275 units on a scale | Standard Deviation 26.1481 |
| Intranasal Saline | Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS) | Suturing Minus Baseline (n = 32, 36) | 29.1328 units on a scale | Standard Deviation 30.6868 |
| Intranasal Midazolam | Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS) | Intervention (n = 30, 36) | 57.9917 units on a scale | Standard Deviation 25.7323 |
| Intranasal Midazolam | Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS) | Suturing Minus Baseline (n = 32, 36) | 12.4897 units on a scale | Standard Deviation 18.95566 |
| Intranasal Midazolam | Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS) | Lidocaine (n = 34, 35) | 60.9596 units on a scale | Standard Deviation 23.29024 |
| Intranasal Midazolam | Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS) | Baseline (n = 33, 36) | 32.9736 units on a scale | Standard Deviation 9.3917 |
p-value: 0.185t-test, 2 sided
p-value: 0.011t-test, 2 sided
p-value: 0.191t-test, 2 sided
p-value: 0.008t-test, 2 sided
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.
Time frame: Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Saline | Per-Protocol: State Trait Anxiety Inventory (STAI) | STAI Pre (n = 32, 34) | 39.3438 units on a scale | Standard Deviation 11.21522 |
| Intranasal Saline | Per-Protocol: State Trait Anxiety Inventory (STAI) | STAI Post (n = 34, 37) | 38.4118 units on a scale | Standard Deviation 12.8184 |
| Intranasal Saline | Per-Protocol: State Trait Anxiety Inventory (STAI) | STAI Post Minus Pre (n = 32, 34) | -0.8750 units on a scale | Standard Deviation 9.1643 |
| Intranasal Midazolam | Per-Protocol: State Trait Anxiety Inventory (STAI) | STAI Pre (n = 32, 34) | 41.7353 units on a scale | Standard Deviation 14.2261 |
| Intranasal Midazolam | Per-Protocol: State Trait Anxiety Inventory (STAI) | STAI Post (n = 34, 37) | 33.7568 units on a scale | Standard Deviation 11.2926 |
| Intranasal Midazolam | Per-Protocol: State Trait Anxiety Inventory (STAI) | STAI Post Minus Pre (n = 32, 34) | -7.6471 units on a scale | Standard Deviation 12.4897 |
p-value: 0.015t-test, 2 sided
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.
Time frame: Day 1: parent asked immediately after procedure complete
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intranasal Saline | Guardian/Parent's Prediction is Respect to Intervention Drug | Intention to Treat (ITT): (Total n = 35, 38) | 25 Times correct |
| Intranasal Saline | Guardian/Parent's Prediction is Respect to Intervention Drug | Per-Protocol (PP): (Total n = 32, 35) | 22 Times correct |
| Intranasal Midazolam | Guardian/Parent's Prediction is Respect to Intervention Drug | Intention to Treat (ITT): (Total n = 35, 38) | 31 Times correct |
| Intranasal Midazolam | Guardian/Parent's Prediction is Respect to Intervention Drug | Per-Protocol (PP): (Total n = 32, 35) | 28 Times correct |
Other Pre-specified
Length of Procedure (Mins)
This is a measure of the length of the procedure (suturing) in minutes.
Time frame: Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Saline | Length of Procedure (Mins) | Intention to Treat (ITT): (n = 36, 39) | 14.72 minutes | Standard Deviation 7.509 |
| Intranasal Saline | Length of Procedure (Mins) | Per-Protocol (PP): (n = 33, 37) | 15.00 minutes | Standard Deviation 7.734 |
| Intranasal Midazolam | Length of Procedure (Mins) | Intention to Treat (ITT): (n = 36, 39) | 23.18 minutes | Standard Deviation 23.374 |
| Intranasal Midazolam | Length of Procedure (Mins) | Per-Protocol (PP): (n = 33, 37) | 23.19 minutes | Standard Deviation 24.014 |
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.
Time frame: Day 1: physician asked immediately after procedure finished
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intranasal Saline | Physician's Prediction is Respect to Intervention Drug | Intention to Treat (ITT): (Total n = 37, 36) | 30 Times correct |
| Intranasal Saline | Physician's Prediction is Respect to Intervention Drug | Per-Protocol (PP): (Total n = 34, 33) | 28 Times correct |
| Intranasal Midazolam | Physician's Prediction is Respect to Intervention Drug | Per-Protocol (PP): (Total n = 34, 33) | 28 Times correct |
| Intranasal Midazolam | Physician's Prediction is Respect to Intervention Drug | Intention to Treat (ITT): (Total n = 37, 36) | 31 Times correct |
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.
Time frame: Day 1: at discharge from emergency department (i.e. same day)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Saline | Time That the Participant Remained in Hospital After Procedure (Mins) | Intentiont to Treat (ITT): (n = 36, 39) | 10.89 minutes | Standard Deviation 12.673 |
| Intranasal Saline | Time That the Participant Remained in Hospital After Procedure (Mins) | Per-Protocol (PP): (n = 33, 37) | 11.24 minutes | Standard Deviation 13.079 |
| Intranasal Midazolam | Time That the Participant Remained in Hospital After Procedure (Mins) | Intentiont to Treat (ITT): (n = 36, 39) | 25.41 minutes | Standard Deviation 26.441 |
| Intranasal Midazolam | Time That the Participant Remained in Hospital After Procedure (Mins) | Per-Protocol (PP): (n = 33, 37) | 25.08 minutes | Standard Deviation 26.99 |