Critical IllnessPhase 2/3NCT00109395
Lorazepam Sedation for Critically Ill Children
A Phase 2/3 study testing Lorazepam, Midazolam and Lorazepam CI in people with Critical Illness, run by The Emmes Company, LLC at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Lorazepam, Midazolam and Lorazepam CI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Sep 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106-6010
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- Lorazepam, Midazolam, Lorazepam CI
- Keywords
- Lorazepam, Midazolam, Best Pharmaceuticals for Children Act, Critically ill, pediatrics, mechanical ventilation, sedation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorazepamDrug
Also called Ativan
Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
MidazolamDrug
Also called Versed
Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
Lorazepam CIDrug
Also called Ativan
Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
| Study group | Role | What they receive |
|---|---|---|
| Lorazepam Intermittent bolus | Active comparator | lorazepam administered by intermittent bolus Receives: Drug: Lorazepam |
| lorazepam continuous infusion | Active comparator | lorazepam administered by continuous infusion Receives: Drug: Lorazepam CI |
| midazolam continous infusion | Active comparator | midazolam administered by continous infusion Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Severe Adverse Events
Duration of study participation
Measured: Minimum 8 hours
Number of bolus doses required to achieve a comfort score of 17 ≤ 26
A measurement of drug efficacy
Measured: minimum of 8 hours
Drug dose required to maintain a target comfort score of 17 ≤ 26
Measurement of efficacy
Measured: Minimum of 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2005 (estimated)
- Study startSep 2004
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Emmes Company, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Case Western Reserve University
- Responsible party
- Sponsor
- Investigators
- Jeffrey L Blumer, MD, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109395
- Sponsor's protocol ID
- HHSN275200403367C (contract)
- Status last verified
- Mar 2023
- First submitted
- 27 Apr 2005
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Lorazepam With Midazolam for Sedation of Mechanically Ventilated Pediatric Patients
- ClinicalTrials.gov ID
- NCT00109395
- Acronym / sponsor ID
- HHSN275200403367C (contract)
- Conditions
- Critical Illness
- Keywords
- Lorazepam, Midazolam, Best Pharmaceuticals for Children Act, Critically ill, pediatrics, mechanical ventilation, sedation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- The Emmes Company, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Case Western Reserve University
- Study start
- Sep 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 28 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lorazepam Intermittent bolus | Active comparator | Drug: Lorazepamlorazepam administered by intermittent bolus |
| lorazepam continuous infusion | Active comparator | Drug: Lorazepam CIlorazepam administered by continuous infusion |
| midazolam continous infusion | Active comparator | Drug: Midazolammidazolam administered by continous infusion |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LorazepamAlso: AtivanIntravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score | Drug | Lorazepam Intermittent bolus |
| MidazolamAlso: VersedIntravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score | Drug | midazolam continous infusion |
| Lorazepam CIAlso: AtivanIntravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score | Drug | lorazepam continuous infusion |
Primary outcome
Rate of Severe Adverse Events
Time frame: Minimum 8 hours
Duration of study participation
Number of bolus doses required to achieve a comfort score of 17 ≤ 26
Time frame: minimum of 8 hours
A measurement of drug efficacy
Drug dose required to maintain a target comfort score of 17 ≤ 26
Time frame: Minimum of 8 hours
Measurement of efficacy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
Related trials for Critical Illness
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Not yet recruiting
Feasibility Study on the Use of a Walking Exoskeleton in the Intensive Care Unit
Neuromuscular Disease in Post-Intensive Care Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey L Blumer, MD, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lorazepam, Midazolam and Lorazepam CI in people with Critical Illness, run by The Emmes Company, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Severe Adverse Events (time frame: Minimum 8 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.