Trial Outcomes & Findings for Hypertonic Saline as Therapy for Pediatric Concussion (NCT NCT01612494)
NCT ID: NCT01612494
Last Updated: 2019-04-16
Results Overview
Self-reported pain assessment using the Wong-Baker Faces Pain Rating Scale. There are 6 faces with 5 intervals. Faces are numbered 0 to 10. Maximum score is the 6th face/10. Minimum score is the first face/0. Increasing faces represent increase in pain, decreasing faces represent decrease in pain. No subscales were included.
COMPLETED
PHASE1/PHASE2
44 participants
Following therapy to 2-3 days post discharge
2019-04-16
Participant Flow
Participants were recruited over the course of one year from a single center's pediatric emergency department
No enrolled patients were excluded from the trial
Participant milestones
| Measure |
Normal Saline
|
Hypertonic Saline
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
|
Overall Study
COMPLETED
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hypertonic Saline as Therapy for Pediatric Concussion
Baseline characteristics by cohort
| Measure |
Normal Saline
n=21 Participants
|
Hypertonic Saline
n=23 Participants
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
44 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
11.9 years
STANDARD_DEVIATION 3 • n=39 Participants
|
12.1 years
STANDARD_DEVIATION 2.5 • n=41 Participants
|
12 years
STANDARD_DEVIATION 3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=39 Participants
|
23 participants
n=41 Participants
|
44 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Following therapy to 2-3 days post dischargeSelf-reported pain assessment using the Wong-Baker Faces Pain Rating Scale. There are 6 faces with 5 intervals. Faces are numbered 0 to 10. Maximum score is the 6th face/10. Minimum score is the first face/0. Increasing faces represent increase in pain, decreasing faces represent decrease in pain. No subscales were included.
Outcome measures
| Measure |
Normal Saline
n=21 Participants
|
Hypertonic Saline
n=23 Participants
|
|---|---|---|
|
Change in Pain
|
1.14 units on a scale
Standard Deviation 1.5
|
3.5 units on a scale
Standard Deviation 1.6
|
Adverse Events
Normal Saline
Hypertonic Saline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Angela Lumba-Brown
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place