Efficacy and Safety of Dexmedetomidine During Weaning From Analgesia and Sedation in PICU (TIP-15-01)

• Status: Terminated
• Trial end date: 2020-01-18
• Target enrollment: 0
• Participant gender: All

Summary

This interventional study evaluates the efficacy of dexmedetomidine during weaning from analgesic and sedative drugs in reducing the occurrence of the withdrawal syndrome in PICU. All enrolled patients will undergo the same weaning regimen one half will receive dexmedetomidine while the other will receive a placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi; IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Collaborators: Azienda Ospedaliera di Padova; Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Policlinico Universitario Agostino Gemelli
• Treatments: Dexmedetomidine; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Continuous analgesic and sedative endovenous treatment for at least 5 days

• Invasive or non-invasive mechanical ventilation

• Clinical conditions that allow by clinical judgment the start of analgosedation weaning

• Post-natal age ≥ 7 days and PMA beyond the 37 weeks

• Written informed consent obtained

Exclusion Criteria:

• Hemodynamic instability

• Cardiac bundle-branch block of 2 or 3 degree

• Hypersensitivity to the alpha-agonists

• Persistent fever of unknown origin or sensitivity to malignant hyperthermia

• Use of alpha-agonist (clonidine or dexmedetomidine) in the last 30 days