Revisiting Survey Investigating Why Patients Are Not Receiving Home Anti-convulsant Medication Prior to Surgery/or Procedure Involving General Anesthesia
1 other identifier
observational
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 26, 2013
CompletedFirst Posted
Study publicly available on registry
July 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedAugust 27, 2014
August 1, 2014
1 year
June 26, 2013
August 26, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Seizure disorder
Patients that are on medications for seizure disorder.
Interventions
Eligibility Criteria
Patients who are taking anti-seizure medications.
You may qualify if:
- We plan to include all children 0-18 years of age on anticonvulsant(s) for seizure disorder.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vidya Ramanlead
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Clinical Professor
Study Record Dates
First Submitted
June 26, 2013
First Posted
July 12, 2013
Study Start
June 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
August 27, 2014
Record last verified: 2014-08