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

University of Oslo (UIO) logo

University of Oslo (UIO)

Status

Completed

Conditions

Critical Care
Child
Drug Withdrawal Symptoms

Treatments

Other: Algorithm for tapering og analgosedation

Study type

Interventional

Funder types

Other

Identifiers

NCT02952846
2016_ASWISPIC

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Before algorithm
No Intervention group
Description:
Observational
After algorithm
Experimental group
Description:
Algorithm for tapering of analgosedation
Treatment:
Other: Algorithm for tapering og analgosedation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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