NCT00109395

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

April 27, 2005

Last Update Submit

March 17, 2023

Conditions

Critical Illness

Keywords

LorazepamMidazolamBest Pharmaceuticals for Children ActCritically illpediatricsmechanical ventilationsedation

Outcome Measures

Primary Outcomes (3)

  • Rate of Severe Adverse Events

    Duration of study participation

    Minimum 8 hours

  • Number of bolus doses required to achieve a comfort score of 17 ≤ 26

    A measurement of drug efficacy

    minimum of 8 hours

  • Drug dose required to maintain a target comfort score of 17 ≤ 26

    Measurement of efficacy

    Minimum of 8 hours

Study Arms (3)

Lorazepam Intermittent bolus

ACTIVE COMPARATOR

lorazepam administered by intermittent bolus

Drug: Lorazepam

lorazepam continuous infusion

ACTIVE COMPARATOR

lorazepam administered by continuous infusion

Drug: Lorazepam CI

midazolam continous infusion

ACTIVE COMPARATOR

midazolam administered by continous infusion

Drug: Midazolam

Interventions

LorazepamDRUG

Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score

Also known as: Ativan
Lorazepam Intermittent bolus
MidazolamDRUG

Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score

Also known as: Versed
midazolam continous infusion
Lorazepam CIDRUG

Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score

Also known as: Ativan
lorazepam continuous infusion

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106-6010, United States

Location

MeSH Terms

Conditions

Critical Illness

Interventions

LorazepamMidazolam

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jeffrey L Blumer, MD, PhD

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2005

First Posted

April 28, 2005

Study Start

September 1, 2004

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

March 20, 2023

Record last verified: 2023-03

Locations

US(1)