Lorazepam Sedation for Critically Ill Children | RxWiki

Lorazepam Sedation for Critically Ill Children

Overview[ - collapse ][ - ]

Purpose	This clinical trial is being performed under the Best Pharmaceuticals for Children Act, signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The purpose of this study is to make sure that lorazepam, when given to children who are very sick in the Intensive Care Unit and who are on a breathing machine, is safe and works as well as a drug called midazolam. Midazolam is already approved by the FDA for this use, but lorazepam is not, even though both drugs are commonly used for sedation.
Condition	Critical Illness
Intervention	Drug: Lorazepam Drug: Midazolam Drug: Lorazepam CI
Phase	Phase 2/Phase 3
Sponsor	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible Party	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier	NCT00109395
First Received	April 27, 2005
Last Updated	December 13, 2011
Last verified	November 2011

Tracking Information[ + expand ][ + ]

First Received Date	April 27, 2005
Last Updated Date	December 13, 2011
Start Date	September 2004
Estimated Primary Completion Date	September 2007
Current Primary Outcome Measures	Rate of Severe Adverse Events [Time Frame: Minimum 8 hours] [Designated as safety issue: Yes]Duration of study participation Number of bolus doses required to achieve a comfort score of 17 ≤ 26 [Time Frame: minimum of 8 hours] [Designated as safety issue: No]A measurement of drug efficacy Drug dose required to maintain a target comfort score of 17 ≤ 26 [Time Frame: Minimum of 8 hours] [Designated as safety issue: No]Measurement of efficacy
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Lorazepam Sedation for Critically Ill Children
Official Title	A Randomized Controlled Trial Comparing Lorazepam With Midazolam for Sedation of Mechanically Ventilated Pediatric Patients
Brief Summary	This clinical trial is being performed under the Best Pharmaceuticals for Children Act, signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The purpose of this study is to make sure that lorazepam, when given to children who are very sick in the Intensive Care Unit and who are on a breathing machine, is safe and works as well as a drug called midazolam. Midazolam is already approved by the FDA for this use, but lorazepam is not, even though both drugs are commonly used for sedation.
Detailed Description	Lorazepam is used clinically for sedation of mechanically ventilated children, but has not been approved by the FDA for this indication in children. The purpose of this study, in response to the Written Request by FDA, is to determine the safety, efficacy, and dosage required for lorazepam compared with midazolam, which is approved by FDA for children for this indication. Study participants must be children who are critically ill and receiving mechanical ventilation who require sedation. Participants will be randomized to lorazepam (intermittent bolus or continuous infusion) or midazolam (continuous infusion). Sedation will be monitored using the COMFORT score. Blood will be drawn to measure lorazepam/midazolam plasma concentrations, and to measure the plasma concentrations of excipients (benzyl alcohol and glycols) in patients receiving lorazepam.
Study Type	Interventional
Study Phase	Phase 2/Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Condition	Critical Illness
Intervention	Drug: Lorazepam Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score Other Names: Ativan Versed Drug: Midazolam Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score Drug: Lorazepam CI Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score Other Names: Ativan Versed
Study Arm (s)	Active Comparator: Lorazepam Intermittent bolus lorazepam administered by intermittent bolus Active Comparator: lorazepam continuous infusion lorazepam administered by continuous infusion Active Comparator: midazolam continous infusion midazolam administered by continous infusion

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	179
Estimated Completion Date	September 2007
Estimated Primary Completion Date	September 2007
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
Gender	Both
Ages	N/A
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00109395
Other Study ID Numbers	HHSN275200403367C (contract)
Has Data Monitoring Committee	Yes
Information Provided By	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Sponsor	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators	Case Western Reserve University
Investigators	Principal Investigator: Jeffrey L Blumer, MD, PhD Case Western Reserve University
Verification Date	November 2011

Locations[ + expand ][ + ]