Lorazepam Sedation for Critically Ill Children

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109395
• Other study ID #: HHSN275200403367C (contract)
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2004
• Est. completion date: September 2007

Study information

• Verified date: March 2023
• Source: The Emmes Company, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• Lorazepam
Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
• Midazolam
Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
• Lorazepam CI
Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Emmes Company, LLC	Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Severe Adverse Events	Duration of study participation	Minimum 8 hours
Primary	Number of bolus doses required to achieve a comfort score of 17 = 26	A measurement of drug efficacy	minimum of 8 hours
Primary	Drug dose required to maintain a target comfort score of 17 = 26	Measurement of efficacy	Minimum of 8 hours