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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.
The investigators plan to conduct ECG evaluation for QT interval both before and after patients are given 2.5 mg of droperidol. Specifically, a convenience sample of consenting adult patients, ages 18 years and older, who present to the ED, and are in a cardiac-monitored bed in the ED who, at the discretion of their treating physician, have an ECG recorded and then receive a dose of 2.5 mg of droperidol IV will be enrolled in our study. The investigators will then have a second ECG printed at least 5 minutes and no more than 30 minutes after the droperidol is given. Change in QT interval between the two ECGs will be documented. It may be necessary to review the EMR in order to document the time of droperidol administration.
These post-droperidol ECGs will not be stored in the electronic medical record nor read by a physician in real time. Treatment decisions regarding the patient's medical care in the ED will not be affected by these second ECGs; decisions about whether other ECGs may be needed will be made by the treating physician. The primary study outcome will be the percentage of the study population who experience a clinically significant increase in QTc after low-dose droperidol administration, defined as an increase in QTc of 20 ms or greater. Secondary outcome measures will be the mean change in QTc across the study population, and the percentage of the study population for whom the administration of low-dose droperidol is associated with an increase in QTc that re-classifies them as having a prolonged QTc (>450 ms in men and >470 ms in women).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Droperidol injection | Drug | 2.5 mg |
| Measure | Description | Time Frame |
|---|---|---|
| ECG Evaluation | We plan to conduct ECG evaluation for QT interval both before and after patients are given 2.5 mg of droperidol. | 30 minutes after Droperidol is given. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aaron K Bartoe, DO, MS | Contact | (863) 532-8408 | aaronkbartoe@gmail.com | |
| Peter Richman, MD, MBA | Contact | prichmanmdmba@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRISTUS Spohn Hospital Corpus Christi-Shoreline | Recruiting | Corpus Christi | Texas | 78405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12351246 | Background | White PF. Droperidol: a cost-effective antiemetic for over thirty years. Anesth Analg. 2002 Oct;95(4):789-90. doi: 10.1097/00000539-200210000-00001. No abstract available. | |
| 24020938 | Background | Trinkley KE, Page RL 2nd, Lien H, Yamanouye K, Tisdale JE. QT interval prolongation and the risk of torsades de pointes: essentials for clinicians. Curr Med Res Opin. 2013 Dec;29(12):1719-26. doi: 10.1185/03007995.2013.840568. Epub 2013 Sep 23. |
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There is no plan to share IPD.
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| ID | Term |
|---|---|
| D004329 | Droperidol |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
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| 22001585 | Background | Pickham D, Helfenbein E, Shinn JA, Chan G, Funk M, Weinacker A, Liu JN, Drew BJ. High prevalence of corrected QT interval prolongation in acutely ill patients is associated with mortality: results of the QT in Practice (QTIP) Study. Crit Care Med. 2012 Feb;40(2):394-9. doi: 10.1097/CCM.0b013e318232db4a. |
| 25083239 | Background | Nachimuthu S, Assar MD, Schussler JM. Drug-induced QT interval prolongation: mechanisms and clinical management. Ther Adv Drug Saf. 2012 Oct;3(5):241-53. doi: 10.1177/2042098612454283. |
| 17519460 | Background | Jackson CW, Sheehan AH, Reddan JG. Evidence-based review of the black-box warning for droperidol. Am J Health Syst Pharm. 2007 Jun 1;64(11):1174-86. doi: 10.2146/ajhp060505. |
| 12109926 | Background | Haddad PM, Anderson IM. Antipsychotic-related QTc prolongation, torsade de pointes and sudden death. Drugs. 2002;62(11):1649-71. doi: 10.2165/00003495-200262110-00006. |
| 10357347 | Background | Domino KB, Anderson EA, Polissar NL, Posner KL. Comparative efficacy and safety of ondansetron, droperidol, and metoclopramide for preventing postoperative nausea and vomiting: a meta-analysis. Anesth Analg. 1999 Jun;88(6):1370-9. doi: 10.1097/00000539-199906000-00032. |
| 15915019 | Background | Charbit B, Albaladejo P, Funck-Brentano C, Legrand M, Samain E, Marty J. Prolongation of QTc interval after postoperative nausea and vomiting treatment by droperidol or ondansetron. Anesthesiology. 2005 Jun;102(6):1094-100. doi: 10.1097/00000542-200506000-00006. |
| 18648229 | Background | Charbit B, Alvarez JC, Dasque E, Abe E, Demolis JL, Funck-Brentano C. Droperidol and ondansetron-induced QT interval prolongation: a clinical drug interaction study. Anesthesiology. 2008 Aug;109(2):206-12. doi: 10.1097/ALN.0b013e31817fd8c8. |
| 15616901 | Background | Abriel H, Schlapfer J, Keller DI, Gavillet B, Buclin T, Biollaz J, Stoller R, Kappenberger L. Molecular and clinical determinants of drug-induced long QT syndrome: an iatrogenic channelopathy. Swiss Med Wkly. 2004 Nov 27;134(47-48):685-94. doi: 10.4414/smw.2004.10532. |
| 32726229 | Background | Cole JB, Lee SC, Martel ML, Smith SW, Biros MH, Miner JR. The Incidence of QT Prolongation and Torsades des Pointes in Patients Receiving Droperidol in an Urban Emergency Department. West J Emerg Med. 2020 Jul 2;21(4):728-736. doi: 10.5811/westjem.2020.4.47036. |
| 9539593 | Background | Fortney JT, Gan TJ, Graczyk S, Wetchler B, Melson T, Khalil S, McKenzie R, Parrillo S, Glass PS, Moote C, Wermeling D, Parasuraman TV, Duncan B, Creed MR. A comparison of the efficacy, safety, and patient satisfaction of ondansetron versus droperidol as antiemetics for elective outpatient surgical procedures. S3A-409 and S3A-410 Study Groups. Anesth Analg. 1998 Apr;86(4):731-8. doi: 10.1097/00000539-199804000-00011. |
| 34959024 | Background | Hernandez-Rodriguez L, Bellolio F, Cabrera D, Mattson AE, VanMeter D, Grush AE, Oliveira J E Silva L. Prospective real-time evaluation of the QTc interval variation after low-dose droperidol among emergency department patients. Am J Emerg Med. 2022 Feb;52:212-219. doi: 10.1016/j.ajem.2021.12.039. Epub 2021 Dec 22. |
| 25293524 | Background | Tracz K, Owczuk R. Small doses of droperidol do not present relevant torsadogenic actions: a double-blind, ondansetron-controlled study. Br J Clin Pharmacol. 2015 Apr;79(4):669-76. doi: 10.1111/bcp.12527. |
| 33075160 | Background | Weibel S, Rucker G, Eberhart LH, Pace NL, Hartl HM, Jordan OL, Mayer D, Riemer M, Schaefer MS, Raj D, Backhaus I, Helf A, Schlesinger T, Kienbaum P, Kranke P. Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis. Cochrane Database Syst Rev. 2020 Oct 19;10(10):CD012859. doi: 10.1002/14651858.CD012859.pub2. |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |