Clinical trial

A Randomized Controlled Trial Comparing Lorazepam With Midazolam for Sedation of Mechanically Ventilated Pediatric Patients

Name

HHSN275200403367C (contract)

Description

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 arms

Trial start

2004-09-01

Estimated PCD

2007-09-01

Trial end

2007-09-01

Status

Completed

Phase

Early phase I

Treatment

Lorazepam

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

Arms:

Lorazepam Intermittent bolus

Other names:

Ativan

Midazolam

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

Arms:

midazolam continous infusion

Other names:

Versed

Lorazepam CI

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

Arms:

lorazepam continuous infusion

Other names:

Ativan

Size

179

Primary endpoint

Rate of Severe Adverse Events

Minimum 8 hours

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

minimum of 8 hours

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

Minimum of 8 hours

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 179, 'type': 'ACTUAL'}}

Updated at

2023-03-20

1 organization

2 products

1 indication

Organization

Product

Indication

Product