Revisiting Survey Investigating Why Patients Are Not Receiving Home Anti-convulsant Medication Prior to Surgery/or Procedure Involving General Anesthesia

Seizures Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897974
• Other study ID #: IRB13-00276
• 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

• Seizures

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