Trial Outcomes & Findings for Procedural Sedation And Analgesia in Children in the Emergency Department: The Role of Adjunct Therapies (NCT NCT02518919)
NCT ID: NCT02518919
Last Updated: 2018-11-27
Results Overview
Total mg/kg of sedation medication administered IV
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
Right at the end of the procedure
Results posted on
2018-11-27
Participant Flow
Patients were screened for eligibility using electronic medical records and if eligible were approached by the study Research Assistant(RA) for informed consent. If the parent/guardian refused participation, were non- English speaking and if parent/legal guardian was not present to complete the informed consent process they were excluded from study
Participant milestones
| Measure |
Standard
Patients will receive intravenous ketamine (1-2mg/kg)
|
Music Listening
Patients will listen to music of their choice using headphones during sedation
Music listening: The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones
|
Child Life Intervention
Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation
Child life intervention: The participants will receive IV ketamine for sedation. In addition in this arm, 'Child Life Intervention', comfort measures provided by a trained child life therapist during painful procedures.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
21
|
|
Overall Study
COMPLETED
|
20
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Standard
Patients will receive intravenous ketamine (1-2mg/kg)
|
Music Listening
Patients will listen to music of their choice using headphones during sedation
Music listening: The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones
|
Child Life Intervention
Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation
Child life intervention: The participants will receive IV ketamine for sedation. In addition in this arm, 'Child Life Intervention', comfort measures provided by a trained child life therapist during painful procedures.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
Baseline Characteristics
Procedural Sedation And Analgesia in Children in the Emergency Department: The Role of Adjunct Therapies
Baseline characteristics by cohort
| Measure |
Standard
n=20 Participants
Patients will receive intravenous ketamine (1-2mg/kg)
|
Music Listening
n=20 Participants
Patients will listen to music of their choice using headphones during sedation
Music listening: The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones
|
Child Life Intervention
n=19 Participants
Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation
Child life intervention: The participants will receive IV ketamine for sedation. In addition in this arm, 'Child Life Intervention', comfort measures provided by a trained child life therapist during painful procedures.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
5 years
n=5 Participants
|
8.5 years
n=7 Participants
|
9 years
n=5 Participants
|
8 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Others
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
American Society of Anesthesiologists(ASA) Classification
American Society of Anesthesiologist, ASA I
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
American Society of Anesthesiologists(ASA) Classification
American Society of Anesethesiologist, ASA II
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Procedure Type
fracture/dislocation reduction
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Procedure Type
Incision and drainage
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Procedure Type
laceration repair
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Pre - sedation pain medication
Pre sedation pain medication yes
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Pre - sedation pain medication
Pre sedation pain medication no
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Right at the end of the procedureTotal mg/kg of sedation medication administered IV
Outcome measures
| Measure |
Standard
n=20 Participants
Patients will receive intravenous ketamine (1-2mg/kg)
|
Music Listening
n=20 Participants
Patients will listen to music of their choice using headphones during sedation
Music listening: The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones
|
Child Life Intervention
n=19 Participants
Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation
Child life intervention: The participants will receive IV ketamine for sedation. In addition in this arm, 'Child Life Intervention', comfort measures provided by a trained child life therapist during painful procedures.
|
|---|---|---|---|
|
Sedation Medication Requirement
|
1.58 mg/kg
Standard Deviation 0.44
|
1.68 mg/kg
Standard Deviation 0.36
|
1.42 mg/kg
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: During the Procedurecompare sedation efficacy among the 3 groups using Ramsey sedation scales and FACES -P (FACES-Pediatric)scale. The Ramsey sedation scales scores sedation at six different levels, according to how arousable the patient is. The continuum of sedation is measured from 1-6 with higher values representing a deeper level of sedation. 1. Patient is anxious and agitated or restless, or both 2. Patient is co-operative, oriented, and tranquil 3. Patient responds to commands only 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6. Patient exhibits no response The Faces- PScale is a self-report measure used to assess the intensity of children's pain. The scale ranges from 0 to 10 with 0 indicating no hurt or discomfort to 10 :hurts most/worst
Outcome measures
| Measure |
Standard
n=20 Participants
Patients will receive intravenous ketamine (1-2mg/kg)
|
Music Listening
n=20 Participants
Patients will listen to music of their choice using headphones during sedation
Music listening: The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones
|
Child Life Intervention
n=19 Participants
Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation
Child life intervention: The participants will receive IV ketamine for sedation. In addition in this arm, 'Child Life Intervention', comfort measures provided by a trained child life therapist during painful procedures.
|
|---|---|---|---|
|
Sedation Efficacy
Ramsay Sedation Score during sedation
|
6 scores on a scale
Interval 4.0 to 6.0
|
6 scores on a scale
Interval 4.0 to 6.0
|
6 scores on a scale
Interval 5.0 to 6.0
|
|
Sedation Efficacy
FACES-Pediatric during sedation
|
0 scores on a scale
Interval 0.0 to 0.0
|
0 scores on a scale
Interval 0.0 to 0.0
|
0 scores on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: during procedure until discharge from the Emergency Departmentdescribe the adverse events experienced by study participants secondary to sedation medication and interventions performed to overcome them
Outcome measures
| Measure |
Standard
n=20 Participants
Patients will receive intravenous ketamine (1-2mg/kg)
|
Music Listening
n=20 Participants
Patients will listen to music of their choice using headphones during sedation
Music listening: The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones
|
Child Life Intervention
n=19 Participants
Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation
Child life intervention: The participants will receive IV ketamine for sedation. In addition in this arm, 'Child Life Intervention', comfort measures provided by a trained child life therapist during painful procedures.
|
|---|---|---|---|
|
Adverse Events
|
4 Participants
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: within two hours of completion of procedureCompare consultant satisfaction among three groups using Likert scale
Outcome measures
| Measure |
Standard
n=20 Participants
Patients will receive intravenous ketamine (1-2mg/kg)
|
Music Listening
n=20 Participants
Patients will listen to music of their choice using headphones during sedation
Music listening: The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones
|
Child Life Intervention
n=19 Participants
Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation
Child life intervention: The participants will receive IV ketamine for sedation. In addition in this arm, 'Child Life Intervention', comfort measures provided by a trained child life therapist during painful procedures.
|
|---|---|---|---|
|
Number of Participants With Consultant Satisfaction Rating as Either" Not Satisfied", "Satisfied", or "Very Satisfied,"
Not satisfied
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Consultant Satisfaction Rating as Either" Not Satisfied", "Satisfied", or "Very Satisfied,"
Satisfied
|
13 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Consultant Satisfaction Rating as Either" Not Satisfied", "Satisfied", or "Very Satisfied,"
Very Satisfied
|
7 Participants
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: during procedurecompare the need for additional dosages of sedation medication among three groups
Outcome measures
| Measure |
Standard
n=20 Participants
Patients will receive intravenous ketamine (1-2mg/kg)
|
Music Listening
n=20 Participants
Patients will listen to music of their choice using headphones during sedation
Music listening: The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones
|
Child Life Intervention
n=19 Participants
Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation
Child life intervention: The participants will receive IV ketamine for sedation. In addition in this arm, 'Child Life Intervention', comfort measures provided by a trained child life therapist during painful procedures.
|
|---|---|---|---|
|
Number of Participants Who Were re- Dosed With Sedation Medication
|
9 Participants
|
4 Participants
|
8 Participants
|
Adverse Events
Standard
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Music Listening
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Child Life Intervention
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard
n=20 participants at risk
Patients will receive intravenous ketamine (1-2mg/kg)
|
Music Listening
n=20 participants at risk
Patients will listen to music of their choice using headphones during sedation
Music listening: The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones
|
Child Life Intervention
n=19 participants at risk
Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation
Child life intervention: The participants will receive IV ketamine for sedation. In addition in this arm, 'Child Life Intervention', comfort measures provided by a trained child life therapist during painful procedures.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oxygen desaturation
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Emesis
|
15.0%
3/20 • Number of events 3
|
40.0%
8/20 • Number of events 8
|
15.8%
3/19 • Number of events 3
|
Additional Information
Dr. Nirupama Kannikeswaran, Associate Professor of Pediatrics and Emergency Medicine
Children's Hospital of Michigan
Phone: 313-745-5260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place