Trial Outcomes & Findings for Intranasal Midazolam for Treatment of Anxiety in Children Undergoing Suturing in the Pediatric Emergency Department (NCT NCT02618772)
NCT ID: NCT02618772
Last Updated: 2016-10-07
Results Overview
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.
COMPLETED
PHASE4
79 participants
Day 1: During suturing
2016-10-07
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
40
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
COMPLETED
|
38
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intranasal Midazolam for Treatment of Anxiety in Children Undergoing Suturing in the Pediatric Emergency Department
Baseline characteristics by cohort
| Measure |
Intranasal Saline
n=39 Participants
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
|
Intranasal Midazolam
n=40 Participants
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
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Intention to Treat (ITT): (n = 39, 40, 79)
|
7.3554 years
STANDARD_DEVIATION 3.2152 • n=5 Participants
|
6.8642 years
STANDARD_DEVIATION 3.5191 • n=7 Participants
|
7.1067 years
STANDARD_DEVIATION 3.35997 • n=5 Participants
|
|
Age, Customized
Per-Protocol (PP): (n = 35, 37, 72)
|
7.3848 years
STANDARD_DEVIATION 3.1826 • n=5 Participants
|
6.8454 years
STANDARD_DEVIATION 3.6318 • n=7 Participants
|
7.1076 years
STANDARD_DEVIATION 3.4077 • n=5 Participants
|
|
Sex/Gender, Customized
Intention to Treat (ITT): Female
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Sex/Gender, Customized
Intention to Treat (ITT): Male
|
29 participants
n=5 Participants
|
25 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Sex/Gender, Customized
Per-Protocol (PP): Female
|
9 participants
n=5 Participants
|
15 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Sex/Gender, Customized
Per-Protocol (PP): Male
|
26 participants
n=5 Participants
|
22 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Laceration Length (cm)
Intention to Treat (ITT): (n = 39, 38, 77)
|
2.395 Centimeters (cm)
STANDARD_DEVIATION 2.2319 • n=5 Participants
|
2.995 Centimeters (cm)
STANDARD_DEVIATION 2.9506 • n=7 Participants
|
2.691 Centimeters (cm)
STANDARD_DEVIATION 2.6116 • n=5 Participants
|
|
Laceration Length (cm)
Per-Protocol (PP): (n = 35, 36, 71)
|
2.389 Centimeters (cm)
STANDARD_DEVIATION 2.3241 • n=5 Participants
|
3.056 Centimeters (cm)
STANDARD_DEVIATION 3.0184 • n=7 Participants
|
2.727 Centimeters (cm)
STANDARD_DEVIATION 2.7003 • n=5 Participants
|
|
Laceration Location: Above Neck
Intention to Treat (ITT)
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Laceration Location: Above Neck
Per-Protocol (PP)
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Laceration Location: Below Neck
Intention to Treat (ITT)
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Laceration Location: Below Neck
Per-Protocol (PP)
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Weight (kg)
Intention to Treat (ITT): (n = 39, 40, 79)
|
27.63 Kilograms (kg)
STANDARD_DEVIATION 10.271 • n=5 Participants
|
27.67 Kilograms (kg)
STANDARD_DEVIATION 17.348 • n=7 Participants
|
27.65 Kilograms (kg)
STANDARD_DEVIATION 14.208 • n=5 Participants
|
|
Weight (kg)
Per-Protocol (PP): (n = 35, 37, 72)
|
27.41 Kilograms (kg)
STANDARD_DEVIATION 10.315 • n=5 Participants
|
28.02 Kilograms (kg)
STANDARD_DEVIATION 18.002 • n=7 Participants
|
27.72 Kilograms (kg)
STANDARD_DEVIATION 14.675 • n=5 Participants
|
|
Triage Vitals: Heart Rate
Intention to Treat (ITT): (n = 13, 14, 27)
|
96.54 Beats per Minute (bpm)
STANDARD_DEVIATION 15.613 • n=5 Participants
|
102.71 Beats per Minute (bpm)
STANDARD_DEVIATION 13.088 • n=7 Participants
|
99.74 Beats per Minute (bpm)
STANDARD_DEVIATION 14.42 • n=5 Participants
|
|
Triage Vitals: Heart Rate
Per-Protocol (PP): (n = 13, 13, 26)
|
96.54 Beats per Minute (bpm)
STANDARD_DEVIATION 15.613 • n=5 Participants
|
102.00 Beats per Minute (bpm)
STANDARD_DEVIATION 13.335 • n=7 Participants
|
99.27 Beats per Minute (bpm)
STANDARD_DEVIATION 14.496 • n=5 Participants
|
|
Triage Vitals: Blood Pressure (Systolic)
Intention to Treat (ITT): (n = 10, 9, 19)
|
110.9 mm Hg
STANDARD_DEVIATION 10.826 • n=5 Participants
|
115.56 mm Hg
STANDARD_DEVIATION 15.915 • n=7 Participants
|
113.11 mm Hg
STANDARD_DEVIATION 13.300 • n=5 Participants
|
|
Triage Vitals: Blood Pressure (Systolic)
Per-Protocol (PP): (n = 10, 9, 19)
|
110.9 mm Hg
STANDARD_DEVIATION 10.826 • n=5 Participants
|
115.56 mm Hg
STANDARD_DEVIATION 15.915 • n=7 Participants
|
113.11 mm Hg
STANDARD_DEVIATION 13.300 • n=5 Participants
|
|
Triage Vitals: Blood Pressure (Diastolic)
Intention to Treat (ITT): (n = 10, 9, 19)
|
66.00 mm Hg
STANDARD_DEVIATION 12.702 • n=5 Participants
|
73.22 mm Hg
STANDARD_DEVIATION 7.759 • n=7 Participants
|
69.42 mm Hg
STANDARD_DEVIATION 11.007 • n=5 Participants
|
|
Triage Vitals: Blood Pressure (Diastolic)
Per-Protocol (PP): (n = 10, 9, 19)
|
66.00 mm Hg
STANDARD_DEVIATION 12.702 • n=5 Participants
|
73.22 mm Hg
STANDARD_DEVIATION 7.759 • n=7 Participants
|
69.42 mm Hg
STANDARD_DEVIATION 11.007 • n=5 Participants
|
|
Triage Vitals: Oxygen Saturation
Intention to Treat (ITT): (n = 9, 9, 18)
|
99.00 Percent (%)
STANDARD_DEVIATION 1.658 • n=5 Participants
|
99.22 Percent (%)
STANDARD_DEVIATION 1.394 • n=7 Participants
|
99.11 Percent (%)
STANDARD_DEVIATION 1.491 • n=5 Participants
|
|
Triage Vitals: Oxygen Saturation
Per-Protocol (PP): (n = 9, 8, 17)
|
99.00 Percent (%)
STANDARD_DEVIATION 1.658 • n=5 Participants
|
99.13 Percent (%)
STANDARD_DEVIATION 1.458 • n=7 Participants
|
99.06 Percent (%)
STANDARD_DEVIATION 1.519 • n=5 Participants
|
|
Nasal Congestion
Intention to Treat (ITT)
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Nasal Congestion
Per-Protocol (PP)
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
LET: Lidocaine, Epinephrine and Tetracaine Gel Use
Intention to Treat (ITT)
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
LET: Lidocaine, Epinephrine and Tetracaine Gel Use
Per-Protocol (PP)
|
21 participants
n=5 Participants
|
24 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1: During suturingPopulation: 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.
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.
Outcome measures
| Measure |
Intranasal Saline
n=34 Participants
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
|
Intranasal Midazolam
n=39 Participants
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
|
|---|---|---|
|
Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)
|
59.9201 units on a scale
Standard Deviation 30.2724
|
46.2871 units on a scale
Standard Deviation 20.5941
|
PRIMARY outcome
Timeframe: Day 1: During suturingPopulation: 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.
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.
Outcome measures
| Measure |
Intranasal Saline
n=35 Participants
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
|
Intranasal Midazolam
n=37 Participants
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
|
|---|---|---|
|
Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)
|
58.7056 units on a scale
Standard Deviation 29.8887
|
45.4633 units on a scale
Standard Deviation 21.20793
|
SECONDARY outcome
Timeframe: Day 1: During Baseline, Intervention & LidocainePopulation: 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.
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.
Outcome measures
| Measure |
Intranasal Saline
n=39 Participants
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
|
Intranasal Midazolam
n=40 Participants
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
|
|---|---|---|
|
Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)
Baseline (n = 35, 38)
|
29.9257 units on a scale
Standard Deviation 8.5783
|
32.9461 units on a scale
Standard Deviation 9.137
|
|
Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)
Intervention (n = 32, 38)
|
45.1373 units on a scale
Standard Deviation 20.9071
|
58.5803 units on a scale
Standard Deviation 25.6165
|
|
Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)
Lidocaine (n = 34, 36)
|
68.8275 units on a scale
Standard Deviation 26.1481
|
61.1871 units on a scale
Standard Deviation 22.9957
|
|
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
|
13.2166 units on a scale
Standard Deviation 18.719
|
SECONDARY outcome
Timeframe: Day 1: Baseline, Intervention & LidocainePopulation: 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.
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.
Outcome measures
| Measure |
Intranasal Saline
n=35 Participants
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
|
Intranasal Midazolam
n=37 Participants
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
|
|---|---|---|
|
Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)
Baseline (n = 33, 36)
|
30.0318 units on a scale
Standard Deviation 8.8073
|
32.9736 units on a scale
Standard Deviation 9.3917
|
|
Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)
Intervention (n = 30, 36)
|
43.0638 units on a scale
Standard Deviation 19.5711
|
57.9917 units on a scale
Standard Deviation 25.7323
|
|
Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)
Lidocaine (n = 34, 35)
|
68.8275 units on a scale
Standard Deviation 26.1481
|
60.9596 units on a scale
Standard Deviation 23.29024
|
|
Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)
Suturing Minus Baseline (n = 32, 36)
|
29.1328 units on a scale
Standard Deviation 30.6868
|
12.4897 units on a scale
Standard Deviation 18.95566
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intranasal Saline
n=39 Participants
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
|
Intranasal Midazolam
n=40 Participants
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
|
|---|---|---|
|
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
|
-8.2162 units on a scale
Standard Deviation 12.4992
|
|
Intention to Treat (ITT): State Trait Anxiety Inventory (STAI)
STAI Pre (n = 36, 37)
|
39.3333 units on a scale
Standard Deviation 11.1867
|
43.1351 units on a scale
Standard Deviation 14.6461
|
|
Intention to Treat (ITT): State Trait Anxiety Inventory (STAI)
STAI Post (n = 37, 40)
|
38.3784 units on a scale
Standard Deviation 12.7788
|
34.5500 units on a scale
Standard Deviation 11.2682
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intranasal Saline
n=35 Participants
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
|
Intranasal Midazolam
n=37 Participants
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
|
|---|---|---|
|
Per-Protocol: State Trait Anxiety Inventory (STAI)
STAI Post Minus Pre (n = 32, 34)
|
-0.8750 units on a scale
Standard Deviation 9.1643
|
-7.6471 units on a scale
Standard Deviation 12.4897
|
|
Per-Protocol: State Trait Anxiety Inventory (STAI)
STAI Pre (n = 32, 34)
|
39.3438 units on a scale
Standard Deviation 11.21522
|
41.7353 units on a scale
Standard Deviation 14.2261
|
|
Per-Protocol: State Trait Anxiety Inventory (STAI)
STAI Post (n = 34, 37)
|
38.4118 units on a scale
Standard Deviation 12.8184
|
33.7568 units on a scale
Standard Deviation 11.2926
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intranasal Saline
n=37 Participants
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
|
Intranasal Midazolam
n=40 Participants
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
|
|---|---|---|
|
Intention to Treat (ITT): Dartmouth Operative Conditions Scale
|
1.92 units on a scale
Standard Deviation 1.949
|
1.15 units on a scale
Standard Deviation 1.847
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intranasal Saline
n=34 Participants
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
|
Intranasal Midazolam
n=37 Participants
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
|
|---|---|---|
|
Per-Protocol: Dartmouth Operative Conditions Scale
|
1.88 units on a scale
Standard Deviation 1.966
|
1.08 units on a scale
Standard Deviation 1.906
|
SECONDARY outcome
Timeframe: Day 1: immediately after interventionPopulation: 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.
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).
Outcome measures
| Measure |
Intranasal Saline
n=38 Participants
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
|
Intranasal Midazolam
n=40 Participants
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
|
|---|---|---|
|
Intention to Treat (ITT): Faces Pain Scale-Revised/ FLACC Scale
|
2.61 units on a scale
Standard Deviation 2.605
|
5.25 units on a scale
Standard Deviation 2.898
|
SECONDARY outcome
Timeframe: Day 1: immediately after interventionPopulation: 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.
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).
Outcome measures
| Measure |
Intranasal Saline
n=34 Participants
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
|
Intranasal Midazolam
n=37 Participants
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
|
|---|---|---|
|
Per-Protocol: Faces Pain Scale-Revised/ FLACC Scale
|
2.47 units on a scale
Standard Deviation 2.608
|
5.19 units on a scale
Standard Deviation 2.895
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Intranasal Saline
n=39 Participants
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
|
Intranasal Midazolam
n=40 Participants
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
|
|---|---|---|
|
Time That the Participant Remained in Hospital After Procedure (Mins)
Intentiont to Treat (ITT): (n = 36, 39)
|
10.89 minutes
Standard Deviation 12.673
|
25.41 minutes
Standard Deviation 26.441
|
|
Time That the Participant Remained in Hospital After Procedure (Mins)
Per-Protocol (PP): (n = 33, 37)
|
11.24 minutes
Standard Deviation 13.079
|
25.08 minutes
Standard Deviation 26.990
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1This is a measure of the length of the procedure (suturing) in minutes.
Outcome measures
| Measure |
Intranasal Saline
n=39 Participants
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
|
Intranasal Midazolam
n=40 Participants
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
|
|---|---|---|
|
Length of Procedure (Mins)
Intention to Treat (ITT): (n = 36, 39)
|
14.72 minutes
Standard Deviation 7.509
|
23.18 minutes
Standard Deviation 23.374
|
|
Length of Procedure (Mins)
Per-Protocol (PP): (n = 33, 37)
|
15.00 minutes
Standard Deviation 7.734
|
23.19 minutes
Standard Deviation 24.014
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1: physician asked immediately after procedure finishedThis 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.
Outcome measures
| Measure |
Intranasal Saline
n=39 Participants
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
|
Intranasal Midazolam
n=40 Participants
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
|
|---|---|---|
|
Physician's Prediction is Respect to Intervention Drug
Intention to Treat (ITT): (Total n = 37, 36)
|
30 Times correct
|
31 Times correct
|
|
Physician's Prediction is Respect to Intervention Drug
Per-Protocol (PP): (Total n = 34, 33)
|
28 Times correct
|
28 Times correct
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1: parent asked immediately after procedure completeThis 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.
Outcome measures
| Measure |
Intranasal Saline
n=39 Participants
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
|
Intranasal Midazolam
n=40 Participants
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
|
|---|---|---|
|
Guardian/Parent's Prediction is Respect to Intervention Drug
Intention to Treat (ITT): (Total n = 35, 38)
|
25 Times correct
|
31 Times correct
|
|
Guardian/Parent's Prediction is Respect to Intervention Drug
Per-Protocol (PP): (Total n = 32, 35)
|
22 Times correct
|
28 Times correct
|
Adverse Events
Intranasal Saline
Intranasal Midazolam
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intranasal Saline
n=39 participants at risk
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
|
Intranasal Midazolam
n=40 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
oxygen saturation less than 92%
|
5.1%
2/39 • Number of events 2
|
2.5%
1/40 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place