Remifentanil for Sedation of Patients With Traumatic Brain Injury (TBI)

Traumatic Brain Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049320
• Other study ID #: IRB13-00478
• Status: Completed
• Phase: N/A
• First received: January 13, 2014
• Last updated: January 31, 2017
• Start date: July 2013
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a descriptive retrospective study designed to measure the efficacy of remifentanil sedation and the ability to perform frequent neurological examinations of patients with traumatic brain injuries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients previously admitted to the hospital presenting with traumatic brain injury (TBI)

• Patients who have undergone sedation after presenting with TBI

Exclusion Criteria:

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Drug:
• Remifentanil

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Joseph D. Tobias

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depth of Sedation	Sedation scores will be assessed.	Every 24 hrs until discharged from the PICU, up to 1 month.