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

NCT03645603 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-11-02

No results posted yet for this study

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.

Conditions

  • Withdrawal Syndrome

Interventions

DRUG

Dexmedetomidine

intravenous infusion

DRUG

Placebo

intravenous infusion of physiological saline solution to mimic dexmedetomidine infusion

Sponsors & Collaborators

  • Azienda Ospedaliera di Padova

    collaborator OTHER

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    collaborator OTHER

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Maria C. Mondardini, MD · Azienda Ospedaliero Universitaria di Bologna Policlinico S.Orsola-Malpighi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-30
Primary Completion
2020-01-18
Completion
2020-01-18

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03645603 on ClinicalTrials.gov