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Effectiveness and Safety Study of Etomidate Versus Midazolam to Help Place a Breathing Tube Outside of the Hospital.

Information source: St. Luke's Hospital, Pennsylvania
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Respiratory Failure

Intervention: Etomidate (20mg) or Midazolam (7mg) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: St. Luke's Hospital, Pennsylvania

Official(s) and/or principal investigator(s):
Jeanne L Jacoby, MD, Principal Investigator, Affiliation: St Luke's Hospital

Summary

The objective of this study was to compare the utility of etomidate and midazolam in helping patients to relax when there was a need for the placement of a ventilation tube by medics who were transporting patients to a hospital in an ambulance.

Clinical Details

Official title: Etomidate Versus Midazolam for Pre-Hospital Intubation: A Prospective, Randomized Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Detailed description: Study Objective: The objective of this study was to compare the utility of etomidate and midazolam for sedative facilitated intubation (SFI), without paralytics, in pre-hospital adult patients. Methods: This prospective, double-blind, randomized trial was conducted with two ground pre-hospital Advanced Life Support (ALS) units. All patients age 18 or over transported by the two participating systems requiring pre-hospital SFI were eligible for participation. The ambulances were stocked with blinded numbered syringes, each containing either 7mg of midazolam or 20mg of etomidate. Contact with the Medic Command physician was not required and no paralytics were used. If sedation was not achieved with the study drug, medics could request additional sedation from a Medical command physician; only midazolam or diazepam were available outside of the study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Under the study protocol, all patients age 18 or over transported by the two participating ALS systems, requiring pre-hospital Sedation Facilitated Intubation, were eligible for participation. Exclusion Criteria: Exclusion criteria were pregnancy and age less than 18.

Locations and Contacts

St. Luke's Hospital, Bethlehem, Pennsylvania 18015, United States
Additional Information

Starting date: October 2002
Last updated: August 28, 2006

Page last updated: August 20, 2015

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