Withdrawal Syndrome Clinical Trial
— TIP-15-01Official title:
Efficacy and Safety of Dexmedetomidine During Weaning From Analgesia and Sedation in Pediatric Intensive Care Unit. A Multicenter, Double-blind, Randomized Controlled Trial.
Verified date | October 2021 |
Source | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 45 |
Est. completion date | January 18, 2020 |
Est. primary completion date | January 18, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | PICU Policlinico S.Orsola-Malpighi | Bologna |
Lead Sponsor | Collaborator |
---|---|
IRCCS Azienda Ospedaliero-Universitaria di Bologna | Azienda Ospedaliera di Padova, Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
Amigoni A, Mondardini MC, Vittadello I, Zaglia F, Rossetti E, Vitale F, Ferrario S, Savron F, Coffaro G, Brugnaro L, Amato R, Wolfler A, Franck LS; Network of Paediatric Intensive Care Unit Study Group (TIPNet). Withdrawal Assessment Tool-1 Monitoring in — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Opioid dose | verification of adherence to weaning regimen | 7 days | |
Other | Change in Sedative dose | verification of adherence to weaning regimen | 7 days | |
Primary | Change in Withdrawal Assessment Tool (WAT-1) scale | WAT-1 score recorded every 12 hours.The score ranges from 0 to 12, a score =3 indicates the presence of signs/symptoms of withdrawal. | time 0 start dexmedetomidine and every 12 hours post-start dexmedetomidine for 7 days | |
Secondary | Change in heart rate | changes in heart rate will be recorded when their value differs more than 20% by the patient's baseline values. | 0,1, 2, 12, 24 hours post-start dexmedetomidine and then every 12 hours for 7 days | |
Secondary | Change in Systolic Blood Pressure | changes in Systolic Blood Pressure will be recorded when their value differs more than 20% by the patient's baseline values. | 0,1, 2, 12, 24 hours post-start dexmedetomidine and then every 12 hours for 7 days | |
Secondary | Change in Diastolic Blood Pressure | changes in Diastolic Blood Pressure will be recorded when their value differs more than 20% by the patient's baseline values. | 0,1, 2, 12, 24 hours post-start dexmedetomidine and then every 12 hours for 7 days |
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