Critical IllnessNCT00441506
Effects of Daily Interruption of Sedatives in Critically Ill Children
A study testing daily interruption of sedatives in people with Critical Illness, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Critically ill children are often sedated in order to relieve them from anxiety and discomfort, and to facilitate their care. There is little information on the effects of prolonged and continuous use of sedatives and analgesic agents in critically ill children. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- daily interruption of sedatives
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2004to Jul 2006
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Intubated and mechanically ventilated for > 24 hours
- Expect further mechanical ventilation for > 48 hours
- Receiving midazolam and morphine for sedation
- Written informed consent given by parents
- Transfer from an outside institution where sedatives had been administered
- Neuromuscular blockers
Show all 14Show fewer
- Metabolic disease
- Neuromuscular disease
- Encephalopathy
- Epilepsy
- Pulmonary hypertension
- Neurotrauma
- Raised intracranial pressure
- Life expectancy less than a month/infaust prognosis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6500HB
About this study
Critically ill children are often sedated in order to relieve them from anxiety and discomfort, and to facilitate their care. There is little information on the effects of prolonged and continuous use of sedatives and analgesic agents in critically ill children. In adult intensive care unit (ICU) patients, daily interruption of sedative infusions accelerates recovery resulting in a reduction in the average duration of mechanical ventilation of 2.4 days as well as a reduction in average ICU length of stay of 3.5 days. These results were achieved without an increased rate of adverse events potentially linked to less sedation and associated with a reduction of common complications of critical illness and without negative psychological effects.
It is unknown whether these results can be extrapolated to critically ill children. Moreover, the possible risk of complications associated with less sedation, such as accidental self-extubation, is probably higher in children. Also, the need for intermittent bolus administrations in children treated with intermittent sedation could nullify the reduction in the use of sedatives.
It is unknown if daily interruption of sedatives is feasible in critically ill children. The researchers studied the effects of daily interruption of sedatives in critically ill children on the total amount of sedatives used and risks of complications.
- Conditions
- Critical Illness
- Being tested
- daily interruption of sedatives
- Keywords
- interruption, critically ill, sedation, pediatrics, critically ill, ventilated children
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daily interruption of sedativesDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of (near) incidents
Measured: Until extubation or 28 days
total amount of sedatives administered
Measured: Until extubation or 28 days
time to wake up (after sedation is stopped), comfort scale
Measured: Until extubation or 28 days
BIS monitoring
Measured: Until extubation or 28 days
Secondary outcomes (2)
time on ventilator
Measured: Until extubation or 28 days
LOS on ICU
Measured: Until extubation or 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startNov 2004
- Primary completionJun 2006
- Study completionJul 2006
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.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Peter Pickkers, MD, PhD, Study director, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441506
- Sponsor's protocol ID
- PP04
- Status last verified
- Feb 2007
- First submitted
- 28 Feb 2007
- Last updated
- 24 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Daily Interruption of Sedatives in Critically Ill Children
- ClinicalTrials.gov ID
- NCT00441506
- Acronym / sponsor ID
- PP04
- Conditions
- Critical Illness
- Keywords
- interruption, critically ill, sedation, pediatrics, critically ill, ventilated children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 1 Mar 2007 (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.
Critically ill children are often sedated in order to relieve them from anxiety and discomfort, and to facilitate their care. There is little information on the effects of prolonged and continuous use of sedatives and analgesic agents in critically ill children. In adult intensive care unit (ICU) patients, daily interruption of sedative infusions accelerates recovery resulting in a reduction in the average duration of mechanical ventilation of 2.4 days as well as a reduction in average ICU length of stay of 3.5 days. These results were achieved without an increased rate of adverse events potentially linked to less sedation and associated with a reduction of common complications of critical illness and without negative psychological effects.
It is unknown whether these results can be extrapolated to critically ill children. Moreover, the possible risk of complications associated with less sedation, such as accidental self-extubation, is probably higher in children. Also, the need for intermittent bolus administrations in children treated with intermittent sedation could nullify the reduction in the use of sedatives.
It is unknown if daily interruption of sedatives is feasible in critically ill children. The researchers studied the effects of daily interruption of sedatives in critically ill children on the total amount of sedatives used and risks of complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Intubated and mechanically ventilated for > 24 hours
- Expect further mechanical ventilation for > 48 hours
- Receiving midazolam and morphine for sedation
- Written informed consent given by parents
- Transfer from an outside institution where sedatives had been administered
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| daily interruption of sedatives | Drug | – |
Primary outcome
amount of (near) incidents
Time frame: Until extubation or 28 days
total amount of sedatives administered
Time frame: Until extubation or 28 days
time to wake up (after sedation is stopped), comfort scale
Time frame: Until extubation or 28 days
BIS monitoring
Time frame: Until extubation or 28 days
2 secondary outcomes
time on ventilator
Time frame: Until extubation or 28 days
LOS on ICU
Time frame: Until extubation or 28 days
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 24 Aug 2010.
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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.
Peter Pickkers, MD, PhD study director
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing daily interruption of sedatives in people with Critical Illness, run by Radboud University Medical Center at 1 site in Netherlands.
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 14 inclusion and 0 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 24 Aug 2010. 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 Netherlands. 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.
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?
amount of (near) incidents (time frame: Until extubation or 28 days). The study lists 4 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 24 Aug 2010.