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

NCT ID: NCT02952846

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2022-04-19

Brief Summary

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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

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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.

Conditions

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Drug Withdrawal Symptoms Critical Care Child

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Before algorithm

Observational

Group Type NO_INTERVENTION

No interventions assigned to this group

After algorithm

Algorithm for tapering of analgosedation

Group Type EXPERIMENTAL

Algorithm for tapering og analgosedation

Intervention Type OTHER

Algorithm for tapering og analgosedation

Interventions

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Algorithm for tapering og analgosedation

Algorithm for tapering og analgosedation

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gunnar Bentsen

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gunnar bentsen, MD PhD

Role: STUDY_CHAIR

Oslo University Hospital

Locations

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Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2016_ASWISPIC

Identifier Type: -

Identifier Source: org_study_id

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