Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT00109395
Eligibility Criteria:
Inclusion Criteria:
* Males or females from full term birth (at least 38 weeks post conceptual age) through 18 years
* Patients must be intubated and mechanically ventilated in the PICU less than or equal to 24 hr
* Patients in whom the use of neuromuscular blocking agents would normally NOT be expected to be used.
* Patient's parent or guardian has signed a consent form prior to initiation of study procedures
* Patients with cardiac, renal, or hepatic dysfunction will be actively sought
Exclusion Criteria:
* Life expectancy \< 48 hr
* Expected duration of sedation \< 48 hr
* Patient with history of hypersensitivity to any component of lorazepam, midazolam, fentanyl, thiopental
* Females pregnant or breast feeding
* Patient requires sedatives or analgesics other than study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
18 Years
Study:
NCT00109395
Study Brief:
Protocol Section:
NCT00109395