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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01897974
Other study ID # IRB13-00276
Secondary ID
Status Completed
Phase N/A
First received June 26, 2013
Last updated August 26, 2014
Start date June 2013
Est. completion date June 2014

Study information

Verified date August 2014
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Children with seizure disorder face unique challenges during the perioperative period. Fasting, sleep-deprivation, and missed doses of medications while patients are required to have nothing per mouth (NPO) are a few factors that decrease the seizure threshold. The incidence of seizures in this population is unknown but correlated with patient's underlying condition and missed doses of anti-convulsant. Previous work has determined this is not a unique problem.

The investigators initially found compliance extremely poor at 60%. The investigators have made improvement to about 80% compliance through various interventions: education of nursing, availability of anticonvulsant intravenous dosing alternatives, and re-wording the hospital NPO policy. The investigators feel that a new, more focused, survey will help identify, perioperative reasons for non-compliance on part of the parents. This information will be utilized to guide further interventions aimed at improving compliance.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- We plan to include all children 0-18 years of age on anticonvulsant(s) for seizure disorder.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Survey
Families complete survey to measure medication compliance.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Vidya Raman

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anticonvuslant compliance Patients/parents will be asked to complete a questionnaire about whether they took their anticonvulsant the morning of surgery and if not, why not. 1 Day No
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