Respiration DisordersNCT00004424
Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy
A study testing fentanyl, Midazolam and propofol in people with Respiration Disorders, run by FDA Office of Orphan Products Development.
Trial summary
OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Respiration Disorders
- What is being tested?
- fentanyl, Midazolam and propofol
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 1996to Mar 2000
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
- Patients admitted to the Rainbow Babies and Children's Hospital Pediatric Intensive Care Unit who require mechanical ventilation and sedation therapy
- Mean COMFORT score must be greater than 26 after 3 consecutive scores are obtained at 2 minute intervals over 6 minutes
- No other concurrent sedative therapy
About this study
OBJECTIVES:
- Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences.
II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam.
III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.
Read the detailed description
PROTOCOL OUTLINE:
This is a randomized, double blind study.
Patients are randomized to receive either a continuous infusion of propofol or a continuous infusion combination of fentanyl and midazolam preceded by a loading dose. Sedative doses may be reduced if necessary. Treatment is continued until sedation is no longer needed, any other sedative therapy is administered, or unacceptable toxicity is experienced.
Patients are assessed after extubation, just prior to hospital discharge, and then every 2 months for 6 months after hospital discharge.
- Conditions
- Respiration Disorders
- Keywords
- disease-related problem/condition, oncologic disorders, pulmonary complications, rare disease, Respiration, Artificial
- Medical subject headings
- Respiration Disorders, Rare Diseases, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startJul 1996
- Study completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- FDA Office of Orphan Products Development
- Sponsor type
- US federal agency
- Collaborators
- Case Western Reserve University
- Investigators
- Michael Deneal Reed, Study chair, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004424
- Sponsor's protocol ID
- 199/13353
- Other IDs
- CWRU-FDR000852
- Status last verified
- Apr 2000
- First submitted
- 18 Oct 1999
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy
- ClinicalTrials.gov ID
- NCT00004424
- Acronym / sponsor ID
- 199/13353
- Conditions
- Respiration Disorders
- Keywords
- disease-related problem/condition, oncologic disorders, pulmonary complications, rare disease, Respiration, Artificial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- FDA Office of Orphan Products DevelopmentUS federal agency
- Collaborators
- Case Western Reserve University
- Study start
- Jul 1996
- Study completion
- Mar 2000
- First posted
- 19 Oct 1999 (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.
OBJECTIVES:
- Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences.
II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam.
III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.
Detailed description
PROTOCOL OUTLINE:
This is a randomized, double blind study.
Patients are randomized to receive either a continuous infusion of propofol or a continuous infusion combination of fentanyl and midazolam preceded by a loading dose. Sedative doses may be reduced if necessary. Treatment is continued until sedation is no longer needed, any other sedative therapy is administered, or unacceptable toxicity is experienced.
Patients are assessed after extubation, just prior to hospital discharge, and then every 2 months for 6 months after hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| fentanyl | Drug | – |
| Midazolam | Drug | – |
| propofol | Drug | – |
Primary outcome
Not reported in the source record.
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 25 Mar 2015.
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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.
Michael Deneal Reed study chair
Case Western Reserve University
Questions about this trial
What is this clinical trial studying?
A study testing fentanyl, Midazolam and propofol in people with Respiration Disorders, run by FDA Office of Orphan Products Development.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
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 25 Mar 2015.