Intravenous infusion of a single solution with with midazolam and fentanyl versus intravenous infusion of midazolam and fentanyl in separate solutions

Phase 3

• Conditions: Respiratory failureSepse; C08.618.846; C01.539.757

• Registration Number: RBR-3j6rdg
• Lead Sponsor: Hospital do Servidor Público Municipal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

A total of 40 consecutive patients will be included; aged between 1 month and 16 years and requiring mechanical ventilation; with an expected mechanical ventilation duration of at least 48 h and requiring sedative/analgesic drugs infusion.

Exclusion Criteria

Patients under 1 month old; patients over 16 years old; presenting severe neurological injury or central nervous system impairment that could affect the assessment of the sedation level. Also; patients will be excluded if they receive any neuromuscular blocking agent or another sedative drug (e.g.; ketamine; dexmedetomedine; clonidine; thiopental; thionembutal; chloral hydrate) during the study period.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the mean difference of the amount (milligrams) of the total cumulated dose of both fentanyl and midazolam administered during the study. The promary outcome will be assessed by calculating the total amount of midazolam and fentanyl (mean) given to each patient at the end of treatment. The increased total dose of both midazolam and fentanyl (mg) over a 6 months period will be assessed through the mean (and standard deviation) of the amount of administered dose (milligrams) from the demonstration of a difference of 100% between the total doses of both midazolam and fentanyl administered for each study group

Secondary Outcome Measures

Name	Time	Method
Mean difference (days) in the mechanical ventilation time between the study groups of patients receiving midazolam and fentanyl combined or separately over a 6 months period will be calculated through the sum of the total time on mechanical ventilation for each patient and then expressed as mean.