Tapering of Analgosedation and Occurrence of Withdrawal Syndrome in Paediatric Intensive Care Treatment (ASWISPIC)
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|ClinicalTrials.gov Identifier: NCT02952846|
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : April 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Drug Withdrawal Symptoms Critical Care Child||Other: Algorithm for tapering og analgosedation||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tapering of Analgosedation and Occurrence of Withdrawal Syndrome in Paediatric Intensive Care Treatment|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
No Intervention: Before algorithm
Experimental: After algorithm
Algorithm for tapering of analgosedation
Other: Algorithm for tapering og analgosedation
Algorithm for tapering og analgosedation
- Change in mean peak WAT-1 score [ Time Frame: Through study completion, up to 21 days ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952846
|Contact: Gunnar Bentsen, MD PhD||+47 email@example.com|
|Contact: Even Fagermoen, MD PhD||+47 firstname.lastname@example.org|
|Oslo University Hospital, Rikshospitalet||Recruiting|
|Oslo, Norway, 0871|
|Contact: Gunnar Bentsen, MD PhD +47 23073700 email@example.com|
|Principal Investigator: Gunnar Bentsen, MD PhD|
|Study Chair:||Gunnar bentsen, MD PhD||Oslo University Hospital|