Tapering of Analgosedation and Occurrence of Withdrawal S... | NCT02952846

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

NCT02952846

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Apr 27, 2022Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Drug Withdrawal Symptoms
Critical Care
Child

Interventions

Algorithm for tapering og analgosedation

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Apr 19, 2022Actual

Completion Date

Apr 19, 2022Actual

First Submitted Date

Aug 30, 2016

First Submission Date that Met QC Criteria

Nov 1, 2016

First Posted Date

Nov 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2022

Last Update Posted Date

Apr 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is a prospective interventional study with three main aims:

Describe the frequency and severity of withdrawal syndrome in a population of paediatric intensive care patients.
Test whether implementation of an algorithm for tapering of analgosedation changes the frequency and severity of withdrawal symptoms in the same population.
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Before algorithm	No Intervention	Observational
After algorithm	Experimental	Algorithm for tapering of analgosedation	Other: Algorithm for tapering og analgosedation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Algorithm for tapering og analgosedation	Other	Algorithm for tapering og analgosedation	After algorithm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Time used tapering analgosedation		Through study completion, up to 21 days
Ventilator days		Through study completion, up to 21 days
ICU days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gunnar bentsen, MD PhD	Oslo University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital, Rikshospitalet		Oslo		0871	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013375	Substance Withdrawal Syndrome

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided