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

Not Applicable

Completed

• Conditions: Drug Withdrawal Symptoms; Child; Critical Care
• Interventions: Other: Algorithm for tapering og analgosedation

• Registration Number: NCT02952846
• Lead Sponsor: Oslo University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-02
• Status Verified: 2022-04
• Primary Completion: 2022-04-19
• Study Completion: 2022-04-19
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
After algorithm	Algorithm for tapering og analgosedation	Algorithm for tapering of analgosedation

Primary Outcome Measures

Name	Time	Method
Change in mean peak WAT-1 score	Through study completion, up to 21 days

Secondary Outcome Measures

Name	Time	Method
Ventilator days	Through study completion, up to 21 days
Adverse events	Through study completion, up to 21 days
Drug doses used	Through study completion, up to 21 days
Time used tapering analgosedation	Through study completion, up to 21 days
ICU days	Through study completion, up to 21 days
Comfort score	Through study completion, up to 21 days

Trial Locations

Locations (1)

Oslo University Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway