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

NCT02952846 — Not applicable, Completed, 80 participants, Oslo University Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT02952846, acronym ASWISPIC
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	80 (Actual)
Sponsor	Oslo University Hospital (Other)
Conditions	Drug Withdrawal Symptoms, Critical Care, Child
Interventions	Algorithm for tapering og analgosedation (Other)
Dates	start 2016-05-01, primary completion 2022-04-19, completion 2022-04-19, first posted 2016-11-02, last updated 2022-04-27
Locations	1 site in Norway

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Before algorithm	No intervention		Observational
After algorithm	Experimental	Other: Algorithm for tapering og analgosedation	Algorithm for tapering of analgosedation

Algorithm for tapering og analgosedation (Other): Algorithm for tapering og analgosedation

+Outcome measures

Primary outcomes

Change in mean peak WAT-1 score [Through study completion, up to 21 days]

Secondary outcomes

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]
Comfort score [Through study completion, up to 21 days]

+Eligibility

Sex: All, ages: any to 18 Years

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

+Locations (1)

Facility	City	Country	Status
Oslo University Hospital, Rikshospitalet	Oslo	Norway

+Investigators

Gunnar bentsen, MD PhD, Study chair, Oslo University Hospital