NCT02952846

Brief Summary

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

  1. 1.Describe the frequency and severity of withdrawal syndrome in a population of paediatric intensive care patients.
  2. 2.Test whether implementation of an algorithm for tapering of analgosedation changes the frequency and severity of withdrawal symptoms in the same population.
  3. 3.Investigate how the health care providers experience having to adhere to such an algorithm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

6 years

First QC Date

August 30, 2016

Last Update Submit

April 19, 2022

Conditions

Drug Withdrawal SymptomsCritical CareChild

Outcome Measures

Primary Outcomes (1)

  • Change in mean peak WAT-1 score

    Through study completion, up to 21 days

Secondary Outcomes (6)

  • Time used tapering analgosedation

    Through study completion, up to 21 days

  • Ventilator days

    Through study completion, up to 21 days

  • ICU days

    Through study completion, up to 21 days

  • Drug doses used

    Through study completion, up to 21 days

  • Adverse events

    Through study completion, up to 21 days

  • +1 more secondary outcomes

Study Arms (2)

Before algorithm

NO INTERVENTION

Observational

After algorithm

EXPERIMENTAL

Algorithm for tapering of analgosedation

Other: Algorithm for tapering og analgosedation

Interventions

Algorithm for tapering og analgosedationOTHER

Algorithm for tapering og analgosedation

After algorithm

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \< 18 years
  • treated in PICU
  • Infusion of opioids and/or benzodiazepins for 5 days or more.

You may not qualify if:

  • Neuromuscular disease
  • Cognitive/neurological disturbance caused by a disease
  • Multiple disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Rikshospitalet

Oslo, 0871, Norway

Location

MeSH Terms

Conditions

Substance Withdrawal Syndrome

Interventions

Algorithms

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Study Officials

  • Gunnar bentsen, MD PhD

    Oslo University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

August 30, 2016

First Posted

November 2, 2016

Study Start

May 1, 2016

Primary Completion

April 19, 2022

Study Completion

April 19, 2022

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)