- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02952846
Tapering of Analgosedation and Occurrence of Withdrawal Syndrome in Paediatric Intensive Care Treatment (ASWISPIC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway, 0871
- Oslo University Hospital, Rikshospitalet
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- < 18 years
- treated in PICU
- Infusion of opioids and/or benzodiazepins for 5 days or more.
Exclusion Criteria:
- Neuromuscular disease
- Cognitive/neurological disturbance caused by a disease
- Multiple disabilities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Before algorithm
Observational
|
|
EXPERIMENTAL: After algorithm
Algorithm for tapering of analgosedation
|
Algorithm for tapering og analgosedation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in mean peak WAT-1 score
Time Frame: Through study completion, up to 21 days
|
Through study completion, up to 21 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time used tapering analgosedation
Time Frame: Through study completion, up to 21 days
|
Through study completion, up to 21 days
|
Ventilator days
Time Frame: Through study completion, up to 21 days
|
Through study completion, up to 21 days
|
ICU days
Time Frame: Through study completion, up to 21 days
|
Through study completion, up to 21 days
|
Drug doses used
Time Frame: Through study completion, up to 21 days
|
Through study completion, up to 21 days
|
Adverse events
Time Frame: Through study completion, up to 21 days
|
Through study completion, up to 21 days
|
Comfort score
Time Frame: Through study completion, up to 21 days
|
Through study completion, up to 21 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gunnar bentsen, MD PhD, Oslo University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016_ASWISPIC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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