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NCT02404077 Clinical Trial

Use of Clonidine to Prevent Withdrawal Following Prolonged Dexmedetomidine Infusions

Sedation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02404077
Other study ID # IRB15-00256
Secondary ID
Status Completed
Phase N/A
First received March 24, 2015
Last updated April 19, 2017
Start date April 2015
Est. completion date March 2017

Study information
Verified date April 2017
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators' clinical practice makes use of oral clonidine as a means of transitioning from intravenous dexmedetomidine following prolonged infusions (more than 3-5 days). Although this is common clinical practice, there is limited clinical data to demonstrate the efficacy of this technique and to provide clonidine dosing guidelines. The purpose of this study is to retrospectively review the investigators' experience with the use of oral clonidine to prevent withdrawal following the prolonged administration of dexmedetomidine.

Recruitment information / eligibility
Status Completed
Enrollment 712
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients who received clonidine during the transition from dexmedetomidine.

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Clonidine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Joseph D. Tobias

Outcome
Type Measure Description Time frame Safety issue
Primary Evidence of withdrawal Withdrawal is assessed using the Withdrawal Assessment Tool-1 (WAT-1). The 19-item assessment consists of (1) a review of the patient's record for the past 12 hours, (2) direct observation of the patient for 2 minutes, (3) patient assessment during a progressive stimulated exam routinely performed to assess level of consciousness at the beginning of each 12-hour shift, and finally (4) assessment of post-stimulus recovery. Twice a day from the first day of taper of dexmedetomidine until 72 hrs. after the last dose
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