Droperidol and QTc Interval Changes in ED Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCHRISTUS Health
About this trial
Objectives To assess the association of low-dose Droperidol administration in the emergency department with changes in the QTc interval.
Hypothesis Our study is designed to test the null hypothesis that there will be no clinically significant change in QTc interval after administration of 2.5mg of IV Droperidol during an emergency department visit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ED patients ages 18 years or older in a cardiovascular-monitored bed who have both an ECG and a 2.5 mg dose of IV droperidol ordered by their treating physician will be eligible for inclusion.
Disqualifiers
Refusal to provide consent.
Administration of droperidol before the first ECG is performed.
Inability to complete the consent form and questionnaire due to clinical instability, severe pain, or disorientation as determined by a study physician.
Trial population
* The population being studied will be a convenience sample of adult emergency department patients. * Eligibility in the study will be based on the treating physician's decision to have administered droperidol and to obtain an ECG - participation in the study will not affect the patient's care. * The minimum number of study subjects will be 100. * The maximum number of study subjects will be 500. * There will be no use of special subject populations. * Investigators will also track how many eligible patients refuse to participate. (See "Participation Status" on the survey instrument, Data Collection Form) * Written consent will be required for each participant at the top of the survey. (See "Survey Instrument", Data Collection Form) * Patients will be enrolled only once. * Participants will not receive any form of compensation and will not be billed for the additional ECG. * Vulnerable adult populations may be included who are able to give consent to participate.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Droperidol injection
Drug2.5 mg
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
ECG Evaluation
We plan to conduct ECG evaluation for QT interval both before and after patients are given 2.5 mg of droperidol.
Time frame
30 minutes after Droperidol is given.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov