Status:
COMPLETED
Ondansetron for Pediatric Mild Traumatic Brain Injury
Lead Sponsor:
St. Justine's Hospital
Conditions:
Traumatic Brain Injury
Brain Concussion
Eligibility:
All Genders
8-17 years
Phase:
PHASE1
Brief Summary
Background: Most patients suffering from mild Traumatic Brain Injury (mTBI) present persistent symptoms at one week post injury. A systematic review showed a paucity of studies for short term outcomes...
Eligibility Criteria
Inclusion
- Children aged between 8 and 17 years old. This will be limited to this small spectrum of age to insure better homogeneity in the evaluation of the participants and streamlining of outcome measures. Also, this is the age group for which our measurement tool has been validated.
- Occurrence of a mTBI as defined by the presence of a head trauma, a Glasgow coma scale of 13 to 15 and at least one of the three following criteria4 :
- Any period of loss of consciousness.
- Any loss of memory for events immediately before or after the accident.
- Any alteration in mental state at the time of the accident (eg, feeling dazed, disoriented).
- And the absence of the following criteria:
- Post-traumatic amnesia greater than 24 hours.
- Glasgow Coma Scale \< 13, 30 minutes post accident.
- The trauma occurred in the preceding 24 hours.
Exclusion
- 1\. Inability to obtain a proper written informed consent (language barrier, absence of a parental authority, developmental delay, intoxication, patient too confuse to consent according to the treating physician).
- 2\. Known allergic reaction or intolerance to ondansetron. 3. Known rhythm or cardiac problem, or history of sudden death in the proximal family 4. Patients who are taking a medication which could increase the QT interval. 5. Patients who received ondansetron in the previous 24 hours 6. Any abnormality on radiological studies, including any bleeding in the brain or skull fracture.
- 7\. Multi-system injuries with treatment requiring admission to hospital or procedural sedation in the ED.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01815125
Start Date
March 1 2013
End Date
February 1 2014
Last Update
September 29 2015
Active Locations (1)
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1
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T1C5