Pain
Conditions
Brief 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.
Interventions
DRUGHypertonic Saline
intravenous formulation of 3% hypertonic saline in a bolus dose of 10ml/kg over one hour
OTHERNormal Saline
intravenous formulation of normal saline in a bolus dose of 10ml/kg over one hour
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* 4-17 years old * consent obtained * pain as a symptom of concussion * head CT negative for intracranial pathology
Exclusion criteria
* younger than 4 years or older than 17 years * multi trauma * cardiac, neuro, renal history of disease * seizure * narcotic, drug use * pregnancy * head CT with traumatic intracranial pathology * no consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain | Following therapy to 2-3 days post discharge | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited over the course of one year from a single center's pediatric emergency department
Pre-assignment details
No enrolled patients were excluded from the trial
Participants by arm
| Arm | Count |
|---|---|
| Normal Saline | 21 |
| Hypertonic Saline | 23 |
| Total | 44 |
Baseline characteristics
| Characteristic | Hypertonic Saline | Normal Saline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 23 Participants | 21 Participants | 44 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12.1 years STANDARD_DEVIATION 2.5 | 11.9 years STANDARD_DEVIATION 3 | 12 years STANDARD_DEVIATION 3 |
| Region of Enrollment United States | 23 participants | 21 participants | 44 participants |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 16 Participants |
| Sex: Female, Male Male | 17 Participants | 11 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 21 | 0 / 23 |
Outcome results
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.
Time frame: Following therapy to 2-3 days post discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline | Change in Pain | 1.14 units on a scale | Standard Deviation 1.5 |
| Hypertonic Saline | Change in Pain | 3.5 units on a scale | Standard Deviation 1.6 |