Trial Outcomes & Findings for Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children (NCT NCT02519595)
NCT ID: NCT02519595
Last Updated: 2016-10-12
Results Overview
Measure sedation depth using Ramsay Sedation Scale. Varies from 1-6 with 1: anxious, agitated, restless 2: Cooperative, oriented, tranquil 3: responsive to commands 4: Brisk response to light glabellar tap or auditory stimulus 5: Sluggish response to light glabellar tap or loud auditory stimulus 6 being no response to light glabellar tap or loud auditory stimulus. Higher the score, greater is the depth of sedation. Use of ketamine usually provides a depth of sedation of 5 or 6.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
182 participants
Primary outcome timeframe
Participants will be assessed after study drug adminsitration and the maximum depth of sedation achieved recorded. Approximately 2 hours
Results posted on
2016-10-12
Participant Flow
Conducted at a level 1 trauma Pediatric Emergency Department from July 1st 2010 to August 31st 2012. We enrolled a convenience sample of eligible patients. Study participants were identified using the electronic medical tracking board which lists the presenting complaint and after need for IV ketamine sedation was established with physician.
11 consented patients were excluded as sedation and procedure was performed in the operating room rather than in the Emergency Department
Participant milestones
| Measure |
Ketamine IV 1 mg/kg
Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg
|
Ketamine IV 1.5 mg/kg
Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg
|
Ketamine IV 2 mg/kg
Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
57
|
56
|
|
Overall Study
COMPLETED
|
50
|
35
|
40
|
|
Overall Study
NOT COMPLETED
|
8
|
22
|
16
|
Reasons for withdrawal
| Measure |
Ketamine IV 1 mg/kg
Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg
|
Ketamine IV 1.5 mg/kg
Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg
|
Ketamine IV 2 mg/kg
Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
8
|
22
|
16
|
Baseline Characteristics
Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children
Baseline characteristics by cohort
| Measure |
Ketamine IV 1 mg/kg
n=50 Participants
Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg
|
Ketamine IV 1.5 mg/kg
n=35 Participants
Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg
|
Ketamine IV 2 mg/kg
n=40 Participants
Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
3-6 years
|
22 participants
n=99 Participants
|
18 participants
n=107 Participants
|
16 participants
n=206 Participants
|
56 participants
n=7 Participants
|
|
Age, Customized
7-12 years
|
22 participants
n=99 Participants
|
13 participants
n=107 Participants
|
18 participants
n=206 Participants
|
53 participants
n=7 Participants
|
|
Age, Customized
13-18 years
|
6 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
16 participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
71 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
102 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
AMerican Society of Anesthesiologists (ASA) Category
ASA Class 1, A normal healthy patient
|
50 participants
n=99 Participants
|
32 participants
n=107 Participants
|
37 participants
n=206 Participants
|
119 participants
n=7 Participants
|
|
AMerican Society of Anesthesiologists (ASA) Category
ASA class 2, Mild systemic disease
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
AMerican Society of Anesthesiologists (ASA) Category
ASA class 3, Severe systemic disease
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Procedure Type
Fracture/Dislocation Reduction
|
33 participants
n=99 Participants
|
21 participants
n=107 Participants
|
35 participants
n=206 Participants
|
89 participants
n=7 Participants
|
|
Procedure Type
Incision and Drainage
|
12 participants
n=99 Participants
|
11 participants
n=107 Participants
|
2 participants
n=206 Participants
|
25 participants
n=7 Participants
|
|
Procedure Type
Laceration Repair
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
11 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Participants will be assessed after study drug adminsitration and the maximum depth of sedation achieved recorded. Approximately 2 hoursMeasure sedation depth using Ramsay Sedation Scale. Varies from 1-6 with 1: anxious, agitated, restless 2: Cooperative, oriented, tranquil 3: responsive to commands 4: Brisk response to light glabellar tap or auditory stimulus 5: Sluggish response to light glabellar tap or loud auditory stimulus 6 being no response to light glabellar tap or loud auditory stimulus. Higher the score, greater is the depth of sedation. Use of ketamine usually provides a depth of sedation of 5 or 6.
Outcome measures
| Measure |
Ketamine IV 1 mg/kg
n=50 Participants
Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg
|
Ketamine IV 1.5 mg/kg
n=35 Participants
Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg
|
Ketamine IV 2 mg/kg
n=40 Participants
Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg
|
|---|---|---|---|
|
Sedation Efficacy
|
5.5 units on a scale
Interval 4.0 to 6.0
|
6 units on a scale
Interval 4.0 to 6.0
|
6 units on a scale
Interval 5.0 to 6.0
|
PRIMARY outcome
Timeframe: Patients will be assessed during the procedure after administration of sedation medicaiton. Approximately 30 minutesMeasure pain using self reported Wong Baker faces pain rating scale prior to sedation, during sedation and prior to discharge.The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". The patient must choose the face that best describes how they are feeling. The score has values of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot),10 (hurts worst). The patient chooses one number that describes the pain best (eg. Either a 2 or 4).
Outcome measures
| Measure |
Ketamine IV 1 mg/kg
n=50 Participants
Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg
|
Ketamine IV 1.5 mg/kg
n=35 Participants
Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg
|
Ketamine IV 2 mg/kg
n=40 Participants
Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg
|
|---|---|---|---|
|
Pain
|
0 units on a scale
Interval 0.0 to 4.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Patients will be assessed during the length of time from administration of sedation medication until ready for discharge, Approximately 3 hoursLength of sedation was defined as the time duration from the administration of study medication until ready for discharge using standardized discharge criteria (Aldrete scoring \>9) followed at our institution.
Outcome measures
| Measure |
Ketamine IV 1 mg/kg
n=50 Participants
Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg
|
Ketamine IV 1.5 mg/kg
n=35 Participants
Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg
|
Ketamine IV 2 mg/kg
n=40 Participants
Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg
|
|---|---|---|---|
|
Sedation Duration
|
23 Minutes
Interval 19.0 to 38.0
|
24.5 Minutes
Interval 17.5 to 34.5
|
23 Minutes
Interval 19.0 to 29.0
|
SECONDARY outcome
Timeframe: Patients will be assessed during procedure . Approximately 1 hoursNumber of participants to whom additional doses of ketamine administered apart from the study dose
Outcome measures
| Measure |
Ketamine IV 1 mg/kg
n=50 Participants
Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg
|
Ketamine IV 1.5 mg/kg
n=35 Participants
Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg
|
Ketamine IV 2 mg/kg
n=40 Participants
Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg
|
|---|---|---|---|
|
Additional Dose
|
8 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Patients will be assessed after administration of medication until discharge and will have a follow up phone call 48 hours after discharge for 3 attempts. 5 days.,Adverse events secondary to sedation experienced by the patient and interventions performed to overcome them
Outcome measures
| Measure |
Ketamine IV 1 mg/kg
n=50 Participants
Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg
|
Ketamine IV 1.5 mg/kg
n=35 Participants
Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg
|
Ketamine IV 2 mg/kg
n=40 Participants
Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg
|
|---|---|---|---|
|
Adverse Events
Adverse events in ED
|
5 participants
|
5 participants
|
4 participants
|
|
Adverse Events
Post discharge Emesis
|
4 participants
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: At the end of the procedure. Approximately 1 hourPopulation: consultant satisfaction missing in 6 participants
Consultants will be asked to rate their level of satisfaction with sedation on a Likert Scale of 1-3
Outcome measures
| Measure |
Ketamine IV 1 mg/kg
n=49 Participants
Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg
|
Ketamine IV 1.5 mg/kg
n=34 Participants
Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg
|
Ketamine IV 2 mg/kg
n=36 Participants
Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg
|
|---|---|---|---|
|
Sedation Satisfaction
Not satisfied
|
10 participants
|
2 participants
|
1 participants
|
|
Sedation Satisfaction
Satisfied
|
12 participants
|
3 participants
|
6 participants
|
|
Sedation Satisfaction
Very Satisfied
|
27 participants
|
29 participants
|
29 participants
|
Adverse Events
Ketamine IV 1 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Ketamine IV 1.5 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Ketamine IV 2 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine IV 1 mg/kg
n=50 participants at risk
Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg
|
Ketamine IV 1.5 mg/kg
n=35 participants at risk
Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg
|
Ketamine IV 2 mg/kg
n=40 participants at risk
Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oxygen Desaturation
|
2.0%
1/50 • Number of events 1
|
5.7%
2/35 • Number of events 2
|
0.00%
0/40
|
|
Gastrointestinal disorders
Emesis
|
2.0%
1/50 • Number of events 1
|
8.6%
3/35 • Number of events 3
|
5.0%
2/40 • Number of events 2
|
|
Nervous system disorders
Unpleasant Recovery Reaction
|
6.0%
3/50 • Number of events 3
|
0.00%
0/35
|
2.5%
1/40 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Others
|
0.00%
0/50
|
0.00%
0/35
|
2.5%
1/40 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place