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

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02952846
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 71.6
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Withdrawal Symptoms; Critical Care; Child	Other: Algorithm for tapering og analgosedation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tapering of Analgosedation and Occurrence of Withdrawal Syndrome in Paediatric Intensive Care Treatment
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Apr 19, 2022
• Actual Study Completion Date: Apr 19, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Before algorithm Observational
Experimental: After algorithm Algorithm for tapering of analgosedation	Other: Algorithm for tapering og analgosedation; Algorithm for tapering og analgosedation

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Time used tapering analgosedation [Through study completion, up to 21 days]

2. Ventilator days [Through study completion, up to 21 days]

3. ICU days [Through study completion, up to 21 days]

4. Drug doses used [Through study completion, up to 21 days]

5. Adverse events [Through study completion, up to 21 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital, Rikshospitalet	Oslo		Norway	0871

Sponsors and Collaborators

• Oslo University Hospital

Investigators

• Study Chair: Gunnar bentsen, MD PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gunnar Bentsen, Consultant, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT02952846
• Other Study ID Numbers: 2016_ASWISPIC
• First Posted: Nov 2, 2016
• Last Update Posted: Apr 27, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Substance Withdrawal Syndrome

Study Results

No Results Posted as of Apr 27, 2022