Sedation with lorazepam in intravenous administration during mechanical ventilation in paediatric intensive care

Phase 1

• Conditions: Critical patients subjected to mechanical ventilation and hospitalized in PICU; MedDRA version: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-003901-93-IT
• Lead Sponsor: IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-21
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Written informed consent of 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 subjected to mechanical ventilation and hospitalized in PICU;
• Patients naïve due to drugs for the analgosedation during ongoing hospitalization.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Hospitalization in PICU less than 48 hours;
• Impaired renal function (estimated GFR according to Schwartz <30 mL / min / 1.73 m2 or creatininemia> 2 vn);
• Altered hepatic function (bilirubin, AST, ALT> 2 UN);
• Altered cardiac function (FE <50%);
• Need for administration of neuromuscular blocking drugs;
• Concomitant therapy with drugs in continuous infusion that contain PG (see table 2)
• Metronidazole therapy in the three months prior to entering the study.
• History of exposure to LZ in the seven days prior to enrollment in the study;
• Participation in other experimental clinical studies;
• Patient undergoing extracorporeal circulation (dialysis, ECMO)
• Known allergic reaction to LZ or its excipients;
• Weight <6 kg;
• Known immaturity of the alcohol dehydrogenase enzyme system;
• Pregnancy in progress;
• Ingestion of antifreeze;
• Treatment with silver sulfadiazine for wound care;
• Diagnosed or suspected oncological pathology.
• Valproic acid therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified