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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Placebo Comparator |
| |
| Hypertonic Saline | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic Saline | Drug | intravenous formulation of 3% hypertonic saline in a bolus dose of 10ml/kg over one hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain | 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. | Following therapy to 2-3 days post discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela K Lumba, MD | University of California, San Diego | Principal Investigator |
| Mary Hilfiker, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital Emergency Department | San Diego | California | 92123 | United States |
No enrolled patients were excluded from the trial
Participants were recruited over the course of one year from a single center's pediatric emergency department
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Saline | |
| FG001 | Hypertonic Saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Saline | |
| BG001 | Hypertonic Saline | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain | 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. | Posted | Mean | Standard Deviation | units on a scale | Following therapy to 2-3 days post discharge |
|
|
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No serious adverse events were reported, collected, or observed during this study. Total number of participants were 44. Other adverse events were not recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Saline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Angela Lumba-Brown | Washington University School of Medicine | 314-362-4325 | lumba_a@kids.wustl.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000077324 | Crystalloid Solutions |
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| Normal Saline | Other | intravenous formulation of normal saline in a bolus dose of 10ml/kg over one hour |
|
|
Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 21 |
| 0 |
| 0 |
| EG001 | Hypertonic Saline | 0 | 23 | 0 | 0 |
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| D007552 |
| Isotonic Solutions |