Hypertonic Saline as Therapy for Pediatric Concussion

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT01612494
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Hypertonic Saline; Other: Normal Saline	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Hypertonic Saline as Therapy for Pediatric Concussion: A Randomized Controlled Trial in the Emergency Department
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Normal Saline	Other: Normal Saline; intravenous formulation of normal saline in a bolus dose of 10ml/kg over one hour; Other Names: NS
Experimental: Hypertonic Saline	Drug: Hypertonic Saline; intravenous formulation of 3% hypertonic saline in a bolus dose of 10ml/kg over one hour; Other Names: 3% HTS

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rady Children's Hospital Emergency Department	San Diego	California	United States	92123

Sponsors and Collaborators

• University of California, San Diego

Investigators

• Principal Investigator: Angela K Lumba, MD, University of California, San Diego
• Principal Investigator: Mary Hilfiker, MD, University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Angela Lumba, MD, Fellow, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT01612494
• Other Study ID Numbers: HTS-100423
• First Posted: Jun 5, 2012
• Last Update Posted: Apr 16, 2019
• Last Verified: Apr 1, 2019

Study Results

Participant Flow

Recruitment Details	Participants were recruited over the course of one year from a single center's pediatric emergency department
Pre-assignment Detail	No enrolled patients were excluded from the trial

Arm/Group Title	Normal Saline	Hypertonic Saline
Arm/Group Description
Period Title: Overall Study
STARTED	21	23
COMPLETED	21	23
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Normal Saline	Hypertonic Saline	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	21	23	44
Age (Count of Participants)
<=18 years	21 100%	23 100%	44 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	11.9 (3)	12.1 (2.5)	12 (3)
Sex: Female, Male (Count of Participants)
Female	10 47.6%	6 26.1%	16 36.4%
Male	11 52.4%	17 73.9%	28 63.6%
Region of Enrollment (participants) [Number]
United States	21 100%	23 100%	44 100%

Outcome Measures

1. Primary Outcome

Title	Change in Pain
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Saline	Hypertonic Saline
Arm/Group Description
Measure Participants	21	23
Mean (Standard Deviation) [units on a scale]	1.14 (1.5)	3.5 (1.6)

Adverse Events

Adverse Event Reporting Description	No serious adverse events were reported, collected, or observed during this study. Total number of participants were 44. Other adverse events were not recorded.
Arm/Group Title	Normal Saline		Hypertonic Saline
Arm/Group Description
All Cause Mortality
	Normal Saline		Hypertonic Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Normal Saline		Hypertonic Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Normal Saline		Hypertonic Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.