Tapering of Analgosedation and Occurrence of Withdrawal Syndrome in Paediatric Intensive Care Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tapering of Analgosedation and Occurrence of Withdrawal Syndrome in Paediatric Intensive Care Treatment

Conditions
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Drug Withdrawal Symptoms, Critical Care, Child

Intervention / Treatment
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* Other: Algorithm for tapering og analgosedation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Before algorithm<br>Observational | |
| Experimental: After algorithm<br>Algorithm for tapering of analgosedation | Other: Algorithm for tapering og analgosedation<br>* Algorithm for tapering og analgosedation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean peak WAT-1 score |  | Through study completion, up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time used tapering analgosedation |  | Through study completion, up to 21 days | 
| Ventilator days |  | Through study completion, up to 21 days | 
| ICU days |  | Through study completion, up to 21 days | 
| Drug doses used |  | Through study completion, up to 21 days | 
| Adverse events |  | Through study completion, up to 21 days | 
| Comfort score |  | Through study completion, up to 21 days |