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

Child Clinical Trial

— ASWISPIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952846
• Other study ID #: 2016_ASWISPIC
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: April 19, 2022

Study information

• Verified date: April 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 19, 2022
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Child
• Critical Care
• Drug Withdrawal Symptoms
• Substance Withdrawal Syndrome

Intervention

Other:
• Algorithm for tapering og analgosedation
Algorithm for tapering og analgosedation

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean peak WAT-1 score		Through study completion, up to 21 days
Secondary	Time used tapering analgosedation		Through study completion, up to 21 days
Secondary	Ventilator days		Through study completion, up to 21 days
Secondary	ICU days		Through study completion, up to 21 days
Secondary	Drug doses used		Through study completion, up to 21 days
Secondary	Adverse events		Through study completion, up to 21 days
Secondary	Comfort score		Through study completion, up to 21 days