Drug Withdrawal SymptomsASWISPICNCT02952846
Tapering of Analgosedation and Occurrence of Withdrawal Syndrome in Paediatric Intensive Care Treatment
A study testing Algorithm for tapering og analgosedation in people with Drug Withdrawal Symptoms and Critical Care, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The study is a prospective interventional study with three main aims: 1. Describe the frequency and severity of withdrawal syndrome in a population of paediatric intensive care patients. 2. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Drug Withdrawal Symptoms, Critical Care, Child
- What is being tested?
- Algorithm for tapering og analgosedation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- May 2016to 19 Apr 2022
- 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
Who may be able to join
- < 18 years
- treated in PICU
- Infusion of opioids and/or benzodiazepins for 5 days or more.
Who cannot join
- Neuromuscular disease
- Cognitive/neurological disturbance caused by a disease
- Multiple disabilities
Trial locations and contacts
1 site in 1 country.
About this study
The study is a prospective interventional study with three main aims:
- Describe the frequency and severity of withdrawal syndrome in a population of paediatric intensive care patients.
- Test whether implementation of an algorithm for tapering of analgosedation changes the frequency and severity of withdrawal symptoms in the same population.
- Investigate how the health care providers experience having to adhere to such an algorithm.
Read the detailed description
Patients < 18 years of age treated in an intensive care unit for 5 days or more with infusion of opioids and/or benzodiazepines, are eligible for inclusion. Patients are included at the time tapering of these drugs is initiated. Part one of the study is observational. Drugs administered, complications, Comfort score and WAT-1 (Withdrawal Assessment Tool-1) score is recorded. Before part two of the study, an algorithm for tapering of analgosedation is implemented, and the data set is obtained as in part one.
For part three of the study, focus group interviews will be used.
- Conditions
- Drug Withdrawal Symptoms, Critical Care, Child
- Being tested
- Algorithm for tapering og analgosedation
- Medical subject headings
- Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm for tapering og analgosedationOther
Algorithm for tapering og analgosedation
| Study group | Role | What they receive |
|---|---|---|
| Before algorithm | No intervention | Observational |
| After algorithm | Experimental | Algorithm for tapering of analgosedation Receives: Other: Algorithm for tapering og analgosedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean peak WAT-1 score
Measured: Through study completion, up to 21 days
Secondary outcomes (6)
Time used tapering analgosedation
Measured: Through study completion, up to 21 days
Ventilator days
Measured: Through study completion, up to 21 days
ICU days
Measured: Through study completion, up to 21 days
Drug doses used
Measured: Through study completion, up to 21 days
Adverse events
Measured: Through study completion, up to 21 days
Comfort score
Measured: Through study completion, up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startMay 2016
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Withdrawal SymptomsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunnar Bentsen, Oslo University Hospital
- Investigators
- Gunnar bentsen, MD PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952846
- Sponsor's protocol ID
- 2016_ASWISPIC
- Acronym
- ASWISPIC
- Status last verified
- Apr 2022
- First submitted
- 30 Aug 2016
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tapering of Analgosedation and Occurrence of Withdrawal Syndrome in Paediatric Intensive Care Treatment
- ClinicalTrials.gov ID
- NCT02952846
- Acronym / sponsor ID
- ASWISPIC / 2016_ASWISPIC
- Conditions
- Drug Withdrawal Symptoms, Critical Care, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 2 Nov 2016 (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.
The study is a prospective interventional study with three main aims:
- Describe the frequency and severity of withdrawal syndrome in a population of paediatric intensive care patients.
- Test whether implementation of an algorithm for tapering of analgosedation changes the frequency and severity of withdrawal symptoms in the same population.
- Investigate how the health care providers experience having to adhere to such an algorithm.
Detailed description
Patients < 18 years of age treated in an intensive care unit for 5 days or more with infusion of opioids and/or benzodiazepines, are eligible for inclusion. Patients are included at the time tapering of these drugs is initiated. Part one of the study is observational. Drugs administered, complications, Comfort score and WAT-1 (Withdrawal Assessment Tool-1) score is recorded. Before part two of the study, an algorithm for tapering of analgosedation is implemented, and the data set is obtained as in part one.
For part three of the study, focus group interviews will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before algorithm | No intervention | –Observational |
| After algorithm | Experimental | Other: Algorithm for tapering og analgosedationAlgorithm for tapering of analgosedation |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- < 18 years
- treated in PICU
- Infusion of opioids and/or benzodiazepins for 5 days or more.
Key exclusion criteria (3 listed)
- Neuromuscular disease
- Cognitive/neurological disturbance caused by a disease
- Multiple disabilities
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 |
|---|---|---|
| Algorithm for tapering og analgosedationAlgorithm for tapering og analgosedation | Other | After algorithm |
Primary outcome
Change in mean peak WAT-1 score
Time frame: Through study completion, up to 21 days
6 secondary outcomes
Time used tapering analgosedation
Time frame: Through study completion, up to 21 days
Ventilator days
Time frame: Through study completion, up to 21 days
ICU days
Time frame: Through study completion, up to 21 days
Drug doses used
Time frame: Through study completion, up to 21 days
Adverse events
Time frame: Through study completion, up to 21 days
Comfort score
Time frame: Through study completion, up to 21 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 27 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Gunnar bentsen, MD PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm for tapering og analgosedation in people with Drug Withdrawal Symptoms and Critical Care, run by Oslo University Hospital at 1 site in Norway.
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 3 inclusion and 3 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 27 Apr 2022. 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 Norway. 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?
Change in mean peak WAT-1 score (time frame: Through study completion, up to 21 days). 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 27 Apr 2022.