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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02952846
Acronym
ASWISPIC
Enrollment
80
Registered
2016-11-02
Start date
2016-05-31
Completion date
2022-04-19
Last updated
2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child, Critical Care, Drug Withdrawal Symptoms

Brief 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. Test whether implementation of an algorithm for tapering of analgosedation changes the frequency and severity of withdrawal symptoms in the same population. 3. 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.

Interventions

OTHERAlgorithm for tapering og analgosedation

Algorithm for tapering og analgosedation

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in mean peak WAT-1 scoreThrough study completion, up to 21 days

Secondary

MeasureTime frame
Ventilator daysThrough study completion, up to 21 days
ICU daysThrough study completion, up to 21 days
Time used tapering analgosedationThrough study completion, up to 21 days
Adverse eventsThrough study completion, up to 21 days
Comfort scoreThrough study completion, up to 21 days
Drug doses usedThrough study completion, up to 21 days

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026