Lorazepam for the Analgosedation of Pediatric Patients in Mechanical Ventilation.

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to better define the pharmacokinetic and pharmacodynamic profile of lorazepam for the analgosedation in pediatric intensive care unit. This will help to better define the dosages and administration modalities (bolus or continue infusion) required to achieve analgosedation with lorazepam in pediatric patients undergoing mechanical ventilation.

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

Details

• Lead Sponsor: Bambino Gesù Hospital and Research Institute
• Collaborators: Ministero della Salute, Italy; University College, London
• Treatments: Lorazepam

Criteria

Inclusion Criteria:

• Informed written consent of the parents or legal representatives of minors according to national law;

• Male and/or female subjects of the following ages: ≥1 year - <12 years;

• Critical patients who need to undergo mechanical ventilation and hospitalized in PICU;

Exclusion Criteria:

• Hospitalization in PICU expected to be less than 48 hours long;

• Altered renal function (eGFR according to Schwartz < 30 mL/min/1.73 m2 or creatininemia > 2 vn);

• Altered liver function (bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 2 NU);

• Altered cardiac function (Ejection Fraction < 50%);

• Need for administration of neuromuscular blocking drugs;

• Concomitant therapy with continuous infusion drugs containing PG;

• Metronidazole therapy in the three months prior to enrollment;

• History of exposure to LZ in the seven days prior to enrollment;

• Participation in other experimental clinical trials;

• Patient undergoing extracorporeal circulation (dialysis, ECMO)

• Known allergic reaction to LZ or its excipients;

• Weight < 9 kg;

• Known immaturity of the enzymatic system of alcohol dehydrogenase;

• Pregnancy in progress;

• Ingestion of antifreeze;

• Treatment with silver sulfadiazine for wound care;

• Oncological pathology diagnosed or suspected;

• Valproic acid therapy

• Patients undergoing continuous infusion therapy with drugs used for sedation prior to admission to the red area (excluding dexmedetomidine).