Trial Outcomes & Findings for Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients (NCT NCT01170247)
NCT ID: NCT01170247
Last Updated: 2017-07-02
Results Overview
Minutes it takes until the patient is cooperative enough for the procedure
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
Every 60 seconds through study completion
Results posted on
2017-07-02
Participant Flow
6 months
Participant milestones
| Measure |
Intranasal Ketamine
Enrolled 2 patients over 6 month period
|
Intramuscular Ketamine
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients
Baseline characteristics by cohort
| Measure |
Intranasal Ketamine
n=2 Participants
|
Intramuscular Ketamine
n=1 Participants
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3 years
STANDARD_DEVIATION 1 • n=5 Participants
|
3 years
STANDARD_DEVIATION NA • n=7 Participants
|
3 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 60 seconds through study completionMinutes it takes until the patient is cooperative enough for the procedure
Outcome measures
| Measure |
Intranasal Ketamine
n=2 Participants
Ketamine: Intranasal Ketamine (100 mg/mL)
|
Intramuscular Ketamine
n=1 Participants
Ketamine: Intramuscular Ketamine
|
|---|---|---|
|
Onset of Sedation
|
NA Participants
Data not collected
|
NA Participants
Data not collected
|
Adverse Events
Intranasal Ketamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intramuscular Ketamine
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