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

Intravenous infusion of a combined solution of midazolam and fentanyl solution vs separated midazolam and fentanyl

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-3j6rdg

Enrollment

Unknown

Registered

2015-08-17

Start date

2016-01-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory failure Sepse

Interventions

Experimental group: 20 patients will receive a continuous intravenous infusion of midazolam and fentanyl combined in a single solution. Each infusion rate of 1 ml/h of solution will provide a dose of

Drug

E03.295

Eligibility

Age

1 Months to 16 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Brazil

Contacts

Public ContactPaulo Sérgio da Silva

Hospital do Servidor Público Municipal

psls.nat@terra.com.br+55 11996015472

Outcome results

None listed

Source: REBEC (via WHO ICTRP)