Trial record 3 of 48 for:    "Brain Concussion"

Ondansetron for Pediatric Mild Traumatic Brain Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jocelyn Gravel, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01815125
First received: March 18, 2013
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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 following mTBI. Among potential treatments for mTBI, ondansetron has shown promising results based on clinical experience and a single retrospective study. Objectives: The primary objective of this pilot study is to determine the feasibility of a randomized controlled trial evaluating the effect of ondansetron to decrease post concussion symptoms at one week following mTBI in children. More specifically, this pilot study will evaluate the proportion of participants who complete assessment at one week following intervention. Method: This will be a randomized, double blinded, controlled trial performed among children aged between 8 and 17 years old who sustained a mTBI in the previous 24 hours. Participants visiting the emergency department will be randomized to receive one dose of either ondansetron or placebo. The primary outcome of interest is defined as an increase from pre-concussion baseline of at least 3 symptoms from the Post Concussion Symptom Inventory (PCSI) one week following trauma. Secondary outcomes will include time to full recovery, mean PCSI score, and outcomes at one month following head trauma. The primary analysis will compare the proportion of participants with persistence of symptoms at one week in both groups. The full study sample size was calculated to have 90% power to detect a decrease in the proportion of persistence of symptoms from 50% to 30% with an alpha value of 0.05. Approximately 126 patients will therefore be recruited in each arm. The investigators plan to recruit 30 participants (10% of the final population) for the pilot study. Expected results: This pilot study should confirm the feasibility of the randomized controlled trial by showing that 90% of the recruited participants provide data on the primary outcome at one week following intervention. On the long term, the investigator expect that ondansetron will decrease the proportion of patients sustaining persistent symptoms of concussion from 50% to lower than 30%.


Condition Intervention Phase
Traumatic Brain Injury
Brain Concussion
Drug: Ondansetron
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ondansetron for Pediatric Mild Traumatic Brain Injury; a Pilot Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Persistence of post concussive symptoms [ Time Frame: 1 week post intervention ] [ Designated as safety issue: No ]
    Persistence of post concussive symptoms will be defined by an increase from pre-concussion baseline of at least 3 symptoms of the Post Concussion Symptom Inventory (PCSI). The PCSI is a self-report tool evaluating the presence of 25 symptoms (on a 3-point likert scale) for children 8-12 and 26 symptoms on a (7-point likert scale) for children 13-17 years. An increase of two points or more from pre-injury in any symptom is considered clinically significant.


Secondary Outcome Measures:
  • Mean number of PCSI symptoms [ Time Frame: one week and month following intervention ] [ Designated as safety issue: No ]
  • Mean number of school days missed [ Time Frame: one month following intervention ] [ Designated as safety issue: No ]
  • Number of days of sport activity restriction [ Time Frame: 1 month following intervention ] [ Designated as safety issue: No ]
  • Time before full recovery [ Time Frame: One month following intervention ] [ Designated as safety issue: No ]
    According to the parents

  • Healthcare utilization [ Time Frame: One month following intervention ] [ Designated as safety issue: No ]
    Proportion of participants who consulted a health resource.

  • Side effects [ Time Frame: one week and month following intervention ] [ Designated as safety issue: Yes ]
    Side effects will include, in addition to symptoms related to mTBI,proportion of participants who complained of diarrhea or constipation (binary answer).


Other Outcome Measures:
  • Proportion of participants who complete the assessment at one week following intervention [ Time Frame: One week following intervention ] [ Designated as safety issue: No ]
    the main objective of the pilot study is to evaluate the feasibility of the randomized controlled trial. Accordingly, the primary outcome of the pilot study will be the proportion of participants who complete the assessment at one week following intervention

  • Proportion of eligible children who were not included [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    This is the proportion of eligible children who were not included and reasons for non-inclusion.

  • Compliance with study medication [ Time Frame: One week following intervention ] [ Designated as safety issue: Yes ]
    Proportion of patients who tolerated their medication and proportion of patients randomized to the control group who received ondansetron


Enrollment: 16
Study Start Date: March 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ondansetron
The intervention of interest will be the administration of one dose of oral ondansetron in the emergency department. The dosage will be 8 mg.
Drug: Ondansetron
The intervention of interest will be the administration of one dose of oral ondansetron in the emergency department. The dosage will be 8 mg.
Other Name: Zofran
Placebo Comparator: Placebo
The control group will receive a similar looking/ tasting pill of placebo.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. The trauma occurred in the preceding 24 hours.

Exclusion Criteria:

  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01815125

Locations
Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T1C5
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Jocelyn Gravel, MD CHU Sainte-JUstine, University of Montreal
  More Information

No publications provided

Responsible Party: Jocelyn Gravel, MD, MSc, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01815125     History of Changes
Other Study ID Numbers: ZOF2013, 9427-c2686-28c
Study First Received: March 18, 2013
Last Updated: February 26, 2014
Health Authority: Canada: Health Canada
Canada: Institutional Review Board
Canada: Quebec Health and Social Services Ministry

Keywords provided by St. Justine's Hospital:
Mild traumatic brain injury
Brain concussion
Post-concussion syndrome
Emergency department
Ondansetron

Additional relevant MeSH terms:
Brain Concussion
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on April 15, 2014