Trial Outcomes & Findings for Pediatric Ketamine Study for Pain Management (NCT NCT02388321)
NCT ID: NCT02388321
Last Updated: 2018-05-08
Results Overview
An 11 point Likert Visual Analog Scale with 0 being no pain, 5 being moderate pain and 10 being very severe pain was verbally administered to the patient at 30 minutes post administration of analgesia.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
30 minutes
Results posted on
2018-05-08
Participant Flow
Participant milestones
| Measure |
Ketamine
intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
|
Fentanyl
intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pediatric Ketamine Study for Pain Management
Baseline characteristics by cohort
| Measure |
Ketamine
n=11 Participants
intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
|
Fentanyl
n=11 Participants
intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.8 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
9.6 years
STANDARD_DEVIATION 2.9 • n=7 Participants
|
9.7 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutesAn 11 point Likert Visual Analog Scale with 0 being no pain, 5 being moderate pain and 10 being very severe pain was verbally administered to the patient at 30 minutes post administration of analgesia.
Outcome measures
| Measure |
Ketamine
n=11 Participants
intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
|
Fentanyl
n=11 Participants
intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
|
|---|---|---|
|
Pain Score at 30 Minutes
|
3.36 units on a scale
Standard Deviation 2.6
|
2.09 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 30 minutesThe patient were asked at 30 minutes post administration of analgesia if they experienced any side effects like nausea, vomiting, headache etc.
Outcome measures
| Measure |
Ketamine
n=11 Participants
intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
|
Fentanyl
n=11 Participants
intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
|
|---|---|---|
|
Adverse Events at 30 Minutes
|
0 Participants
|
0 Participants
|
Adverse Events
Ketamine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Fentanyl
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine
n=11 participants at risk
intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
|
Fentanyl
n=11 participants at risk
intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
|
|---|---|---|
|
Nervous system disorders
Dizzines
|
45.5%
5/11 • Number of events 5
|
9.1%
1/11 • Number of events 1
|
Additional Information
Sergey Motov, MD (Prinicipal Investigator)
Maimonides Medical Center
Phone: 718-283-8693
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place