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NCT01612494 · ClinicalTrials.gov registry record · Phase 1
Hypertonic Saline as Therapy for Pediatric Concussion
A Phase 1 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT01612494: Completed Phase 1 study, sponsored by University of California, San Diego.
NCT01612494 is a Phase 1 study that has completed, run by University of California, San Diego. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01612494, a Phase 1 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
This single center, blinded, randomized controlled trial evaluated the use of hypertonic saline versus normal saline as therapy for the symptoms of pediatric concussion post head injury. The study hypothesis was that hypertonic saline would improve symptoms of pediatric concussion following head injury as measured on the self-reported Wong Baker Faces Pain Scale as compared to normal saline. The null hypothesis was that there would be no difference in change of reported pain in either group.
Primary Outcome
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.
Interventions
- OTHER Normal Saline
- DRUG Hypertonic Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
What the finished NCT01612494 record still lists
NCT01612494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT01612494 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01612494 about?
NCT01612494 is a clinical study titled "Hypertonic Saline as Therapy for Pediatric Concussion". This single center, blinded, randomized controlled trial evaluated the use of hypertonic saline versus normal saline as therapy for the symptoms of pediatric concussion post head injury. The study hypothesis was that hypertonic saline would improve symptoms of pediatric concussion following head in...
What is the current status of trial NCT01612494?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2010-03. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01612494?
The interventions under investigation include: Normal Saline (OTHER), Hypertonic Saline (DRUG).
Who is sponsoring clinical trial NCT01612494?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01612494's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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