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Trial record 63 of 303 for:    Recruiting, Not yet recruiting, Available Studies | Pediatrics

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

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ClinicalTrials.gov Identifier: NCT02952846
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Gunnar Bentsen, 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.

Condition or disease Intervention/treatment Phase
Drug Withdrawal Symptoms Critical Care Child Other: Algorithm for tapering og analgosedation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in mean peak WAT-1 score [ Time Frame: Through study completion, up to 21 days ]

Secondary Outcome Measures :
  1. Time used tapering analgosedation [ Time Frame: Through study completion, up to 21 days ]
  2. Ventilator days [ Time Frame: Through study completion, up to 21 days ]
  3. ICU days [ Time Frame: Through study completion, up to 21 days ]
  4. Drug doses used [ Time Frame: Through study completion, up to 21 days ]
  5. Adverse events [ Time Frame: Through study completion, up to 21 days ]
  6. Comfort score [ Time Frame: Through study completion, up to 21 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952846


Contacts
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Contact: Gunnar Bentsen, MD PhD +47 23070000 gbentsen@ous-hf.no
Contact: Even Fagermoen, MD PhD +47 23070000 evefag@ous-hf.no

Locations
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Norway
Oslo University Hospital, Rikshospitalet Recruiting
Oslo, Norway, 0871
Contact: Gunnar Bentsen, MD PhD    +47 23073700    gbentsen@ous-hf.no   
Principal Investigator: Gunnar Bentsen, MD PhD         
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Study Chair: Gunnar bentsen, MD PhD Oslo University Hospital

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Responsible Party: Gunnar Bentsen, Consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02952846     History of Changes
Other Study ID Numbers: 2016_ASWISPIC
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders