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

Primary Purpose

Drug Withdrawal Symptoms, Critical Care, Child

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Algorithm for tapering og analgosedation

About this trial

This is an interventional treatment trial for Drug Withdrawal Symptoms

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oslo University Hospital, Rikshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Before algorithm

After algorithm

Arm Description

Observational

Algorithm for tapering of analgosedation

Outcomes

Primary Outcome Measures

Change in mean peak WAT-1 score

Secondary Outcome Measures

Time used tapering analgosedation

Ventilator days

ICU days

Drug doses used

Adverse events

Comfort score

Full Information

NCT ID

NCT02952846

First Posted

August 30, 2016

Last Updated

April 19, 2022

Sponsor

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02952846

Brief Title

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

Acronym

ASWISPIC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

May 2016 (undefined)

Primary Completion Date

April 19, 2022 (Actual)

Study Completion Date

April 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug Withdrawal Symptoms, Critical Care, Child

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Before algorithm

Arm Type

No Intervention

Arm Description

Observational

Arm Title

After algorithm

Arm Type

Experimental

Arm Description

Algorithm for tapering of analgosedation

Intervention Type

Other

Intervention Name(s)

Algorithm for tapering og analgosedation

Intervention Description

Algorithm for tapering og analgosedation

Primary Outcome Measure Information:

Title

Change in mean peak WAT-1 score

Time Frame