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Lorazepam Sedation for Critically Ill Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00109395
Recruitment Status : Completed
First Posted : April 28, 2005
Last Update Posted : March 20, 2023
Sponsor:
Collaborator:
Case Western Reserve University
Information provided by (Responsible Party):
The Emmes Company, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Critical Illness Drug: Lorazepam Drug: Midazolam Drug: Lorazepam CI Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Lorazepam With Midazolam for Sedation of Mechanically Ventilated Pediatric Patients
Study Start Date : September 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lorazepam Intermittent bolus
lorazepam administered by intermittent bolus
 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 Name: Ativan
Active Comparator: lorazepam continuous infusion
lorazepam administered by continuous infusion
 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 Name: Ativan
Active Comparator: midazolam continous infusion
midazolam administered by continous infusion
 Drug: Midazolam
Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
Other Name: Versed


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Severe Adverse Events [ Time Frame: Minimum 8 hours ]
    Duration of study participation

  2. Number of bolus doses required to achieve a comfort score of 17 ≤ 26 [ Time Frame: minimum of 8 hours ]
    A measurement of drug efficacy

  3. Drug dose required to maintain a target comfort score of 17 ≤ 26 [ Time Frame: Minimum of 8 hours ]
    Measurement of efficacy


Eligibility Criteria
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Ages Eligible for Study:   1 Day to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109395


Locations
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United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106-6010
Sponsors and Collaborators
The Emmes Company, LLC
Case Western Reserve University
Investigators
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Principal Investigator: Jeffrey L Blumer, MD, PhD Case Western Reserve University
More Information
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Responsible Party: The Emmes Company, LLC
ClinicalTrials.gov Identifier: NCT00109395    
Other Study ID Numbers: HHSN275200403367C (contract)
First Posted: April 28, 2005    Key Record Dates
Last Update Posted: March 20, 2023
Last Verified: March 2023
Keywords provided by The Emmes Company, LLC:
Lorazepam
Midazolam
Best Pharmaceuticals for Children Act
Critically ill
 pediatrics
mechanical ventilation
sedation
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Midazolam
Lorazepam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents