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

April 19, 2022 updated by: Gunnar Bentsen, Oslo University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0871
        • Oslo University Hospital, Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Before algorithm
Observational
EXPERIMENTAL: After algorithm
Algorithm for tapering of analgosedation
Other: Algorithm for tapering og analgosedation
Algorithm for tapering og analgosedation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Study Chair: Gunnar bentsen, MD PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

April 19, 2022

Study Completion (ACTUAL)

April 19, 2022

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (ESTIMATE)

November 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016_ASWISPIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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