- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01897974
Revisiting Survey Investigating Why Patients Are Not Receiving Home Anti-convulsant Medication Prior to Surgery/or Procedure Involving General Anesthesia
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.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- We plan to include all children 0-18 years of age on anticonvulsant(s) for seizure disorder.
Exclusion Criteria:
- None.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Seizure disorder
Patients that are on medications for seizure disorder.
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Families complete survey to measure medication compliance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anticonvuslant compliance
Time Frame: 1 Day
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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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB13-00276
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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