Trial Outcomes & Findings for Improving Sedation of Children Undergoing Procedures in the Emergency Department (NCT NCT00675909)
NCT ID: NCT00675909
Last Updated: 2018-11-09
Results Overview
Modified CHEOPS (Children's Hospital of Eastern Ontario Pain Scale)assessment used to score sedation. Scale range is 0-10 with 0 meaning no pain and 4 or greater meaning pain. Scale is determined by assessing Facial Expression (0-2), Cry (0-3), Child Verbal (0-2) and Movements (0-3).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
Baseline (presentation, before sedation) in ED to start of procedure (laceration repair).
Results posted on
2018-11-09
Participant Flow
Enrollment November 2006-January 2010 from the Emergency Department at Seattle Children's Hospital
Participant milestones
| Measure |
Oral Midazolam
Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.
0.5mg/kg of midazolam taken orally.
|
Buccal Midazolam
Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.
0.3mg/kg total dose administered with aerosolization device ("atomizer") sprayed onto buccal mucosa inside the cheek on both sides of mouth.
|
Intranasal Midazolam
Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.
Midazolam will be administered via aerosolization (using "atomizer") with half of dose in each nostril. Total dose is 0.3mg/kg.
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Sedation of Children Undergoing Procedures in the Emergency Department
Baseline characteristics by cohort
| Measure |
Oral Midazolam
n=60 Participants
Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.
0.5mg/kg of midazolam taken orally.
|
Buccal Midazolam
n=60 Participants
Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.
0.3mg/kg total dose administered with aerosolization device ("atomizer") sprayed onto buccal mucosa inside the cheek on both sides of mouth.
|
Intranasal Midazolam
n=60 Participants
Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.
Midazolam will be administered via aerosolization (using "atomizer") with half of dose in each nostril. Total dose is 0.3mg/kg.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
60 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
180 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
3.1 years
STANDARD_DEVIATION 1.5 • n=99 Participants
|
3.7 years
STANDARD_DEVIATION 1.4 • n=107 Participants
|
3.2 years
STANDARD_DEVIATION 1.3 • n=206 Participants
|
3.3 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
67 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
113 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=99 Participants
|
60 participants
n=107 Participants
|
60 participants
n=206 Participants
|
180 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline (presentation, before sedation) in ED to start of procedure (laceration repair).Population: Intention to treat
Modified CHEOPS (Children's Hospital of Eastern Ontario Pain Scale)assessment used to score sedation. Scale range is 0-10 with 0 meaning no pain and 4 or greater meaning pain. Scale is determined by assessing Facial Expression (0-2), Cry (0-3), Child Verbal (0-2) and Movements (0-3).
Outcome measures
| Measure |
Oral Midazolam
n=56 Participants
Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.
0.5mg/kg of midazolam taken orally.
|
Intranasal Midazolam
n=55 Participants
Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.
Midazolam will be administered via aerosolization (using "atomizer") with half of dose in each nostril. Total dose is 0.3mg/kg.
|
Buccal Midazolam
n=58 Participants
Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.
0.3mg/kg total dose administered with aerosolization device ("atomizer") sprayed onto buccal mucosa inside the cheek on both sides of mouth.
|
|---|---|---|---|
|
Change in CHEOPS Score Measured Level of Sedation From Baseline (Presentation in ED, Before Sedation) to Start of Procedure (Laceration Repair).
|
2 Scores on a scale
Interval -2.0 to 7.0
|
2 Scores on a scale
Interval -3.0 to 7.0
|
1 Scores on a scale
Interval -6.0 to 6.0
|
SECONDARY outcome
Timeframe: Time from study drug administration to start of procedure up to 68 minutesOutcome measures
| Measure |
Oral Midazolam
n=58 Participants
Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.
0.5mg/kg of midazolam taken orally.
|
Intranasal Midazolam
n=55 Participants
Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.
Midazolam will be administered via aerosolization (using "atomizer") with half of dose in each nostril. Total dose is 0.3mg/kg.
|
Buccal Midazolam
n=58 Participants
Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.
0.3mg/kg total dose administered with aerosolization device ("atomizer") sprayed onto buccal mucosa inside the cheek on both sides of mouth.
|
|---|---|---|---|
|
Time From Study Drug Administration to Start of Procedure
|
34 minutes
Interval 11.0 to 68.0
|
28 minutes
Interval 5.0 to 60.0
|
32 minutes
Interval 10.0 to 59.0
|
SECONDARY outcome
Timeframe: Duration of procedure up to 40 minutesOutcome measures
| Measure |
Oral Midazolam
n=58 Participants
Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.
0.5mg/kg of midazolam taken orally.
|
Intranasal Midazolam
n=54 Participants
Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.
Midazolam will be administered via aerosolization (using "atomizer") with half of dose in each nostril. Total dose is 0.3mg/kg.
|
Buccal Midazolam
n=58 Participants
Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.
0.3mg/kg total dose administered with aerosolization device ("atomizer") sprayed onto buccal mucosa inside the cheek on both sides of mouth.
|
|---|---|---|---|
|
Duration of Procedure
|
12 minutes
Interval 1.0 to 40.0
|
12 minutes
Interval 1.0 to 40.0
|
10 minutes
Interval 1.0 to 39.0
|
SECONDARY outcome
Timeframe: Physician was asked after the procedure was done about their impression of sedation.Range is 0-10. Higher is associated with physician impression that sedation is better.
Outcome measures
| Measure |
Oral Midazolam
n=57 Participants
Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.
0.5mg/kg of midazolam taken orally.
|
Intranasal Midazolam
n=52 Participants
Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.
Midazolam will be administered via aerosolization (using "atomizer") with half of dose in each nostril. Total dose is 0.3mg/kg.
|
Buccal Midazolam
n=58 Participants
Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.
0.3mg/kg total dose administered with aerosolization device ("atomizer") sprayed onto buccal mucosa inside the cheek on both sides of mouth.
|
|---|---|---|---|
|
Physician Rating of Sedation
|
6.7 units on a scale
Interval 0.0 to 10.0
|
8.1 units on a scale
Interval 1.0 to 10.0
|
7.1 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: After the procedure nurse was asked about their impression of the level of sedation.Range is 0-10. Higher is associated with nurse impression that sedation is better.
Outcome measures
| Measure |
Oral Midazolam
n=43 Participants
Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.
0.5mg/kg of midazolam taken orally.
|
Intranasal Midazolam
n=44 Participants
Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.
Midazolam will be administered via aerosolization (using "atomizer") with half of dose in each nostril. Total dose is 0.3mg/kg.
|
Buccal Midazolam
n=44 Participants
Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.
0.3mg/kg total dose administered with aerosolization device ("atomizer") sprayed onto buccal mucosa inside the cheek on both sides of mouth.
|
|---|---|---|---|
|
Nurse Rating of Sedation
|
6.8 units on a scale
Interval 0.0 to 10.0
|
7.7 units on a scale
Interval 1.0 to 10.0
|
7.6 units on a scale
Interval 0.0 to 10.0
|
Adverse Events
Oral Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Buccal Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intranasal Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place