Skip to main content
OpenTrials
Completed

NCT Number: NCT02952846

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Drug Withdrawal Symptoms Chemically-Induced Disorders Child Critical Care Mental Disorders Substance Withdrawal Syndrome Substance-Related Disorders

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Rikshospitalet

Oslo, 0871, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Algorithm for tapering og analgosedation

Other

Algorithm for tapering og analgosedation

Primary outcomes

  1. Change in mean peak WAT-1 score

    Time frame: Through study completion, up to 21 days

Secondary outcomes

  1. Time used tapering analgosedation

    Time frame: Through study completion, up to 21 days

  2. Ventilator days

    Time frame: Through study completion, up to 21 days

  3. ICU days

    Time frame: Through study completion, up to 21 days

  4. Drug doses used

    Time frame: Through study completion, up to 21 days

  5. Adverse events

    Time frame: Through study completion, up to 21 days

  6. Comfort score

    Time frame: Through study completion, up to 21 days

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Acronym: ASWISPIC

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Nov 2, 2016
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.