Lorazepam Sedation for Critically Ill Children

This study has been completed.
Sponsor:
Collaborator:
Case Western Reserve University
Information provided by (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

April 27, 2005
December 13, 2011
September 2004
September 2007   (final data collection date for primary outcome measure)
  • 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
Efficacy of lorazepam relative to midazolam for initiation and maintenance of sedation in mechanically ventilated children
Complete list of historical versions of study NCT00109395 on ClinicalTrials.gov Archive Site
Not Provided
  • Adequacy of sedation
  • Time to adequate sedation
  • Severe Adverse Event rate and description
  • Occurrence of "critical or near critical" incidents related to inadequate sedation or analgesic agents
Not Provided
Not Provided
 
Lorazepam Sedation for Critically Ill Children
A Randomized Controlled Trial Comparing Lorazepam With Midazolam for Sedation of Mechanically Ventilated Pediatric Patients

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Critical Illness
  • 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
  • Active Comparator: Lorazepam Intermittent bolus
    lorazepam administered by intermittent bolus
    Intervention: Drug: Lorazepam
  • Active Comparator: lorazepam continuous infusion
    lorazepam administered by continuous infusion
    Intervention: Drug: Lorazepam CI
  • Active Comparator: midazolam continous infusion
    midazolam administered by continous infusion
    Intervention: Drug: Midazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00109395
HHSN275200403367C (contract)
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
Principal Investigator: Jeffrey L Blumer, MD, PhD Case Western Reserve University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP