Lorazepam Sedation for Critically Ill Children
Information source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Critical Illness
Intervention: Lorazepam (Drug); Midazolam (Drug); Lorazepam CI (Drug)
Phase: Phase 2/Phase 3
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Official(s) and/or principal investigator(s):
Jeffrey L Blumer, MD, PhD, Principal Investigator, Affiliation: Case Western Reserve University
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.
Official title: A Randomized Controlled Trial Comparing Lorazepam With Midazolam for Sedation of Mechanically Ventilated Pediatric Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Rate of Severe Adverse Events
Number of bolus doses required to achieve a comfort score of 17 ≤ 26
Drug dose required to maintain a target comfort score of 17 ≤ 26
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
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.
Minimum age: N/A.
Maximum age: 18 Years.
- Males or females from full term birth (at least 38 weeks post conceptual age) through
- 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
- Patients with cardiac, renal, or hepatic dysfunction will be actively sought
- Life expectancy < 48 hr
- Expected duration of sedation < 48 hr
- Patient with history of hypersensitivity to any component of lorazepam, midazolam,
- Females pregnant or breast feeding
- Patient requires sedatives or analgesics other than study drug
Locations and Contacts
Case Western Reserve University, Cleveland, Ohio 44106-6010, United States
Starting date: September 2004
Last updated: December 13, 2011