Ondansetron and the QT Interval In Adult Emergency Department Patients

Completed

Conditions studied: Ondansetron

In brief

The purpose of this study is to assess the use of the medication ondansetron (zofran) in the emergency department. There are studies of the ability of ondansetron to cause a prolongation in the QT interval (a certain measurement on an EKG) in anesthesia and cancer patients, but not on emergency department patients. This is an observational study where patients that are going to receive the anti-nausea medicine ondansetron in the emergency department will have an EKG performed every 2 minutes for 20 minutes to determine if the QT interval prolongs and returns to normal in that time period. Any serious outcomes will be reported. There is expected to be no adverse outcomes from this routinely used medication.

Key facts

Study ID

NCT01759420

Run by

C.R.Darnall Army Medical Center

People needed

28

Starts

2012-12-01

Expected to finish

2014-05-01

Last updated by the study team

2014-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18
• Patient to receive 4mg of intravenous ondansetron

You may not qualify if…

• Age <18
• known long QT syndrome
• received oral or intravenous ondansetron within 4 hours of enrollment
• co-administration of any known QT prolonging agents
• QTc on baseline of >450 ms for males and >470ms for females
• allergy or known hypersensitivity to ondansetron
• altered mental status
• non-sinus rhythm on baseline EKG
• hypokalemia (as defined by the lower limit of normal for the reference laboratory)
• hypomagnesemia (as defined by the lower limit of normal for the reference laboratory)
• any presentation for chest pain with signs of ischemia on baseline EKG
• QRS duration > 120 msec
• bundle branch block (right or left)
• ventricular pre-excitation or signs of left ventricular hypertrophy with repolarization abnormalities

Where it is running

• Carl R Darnall Army Medical Center — Fort Hood, Texas, United States
• Madigan Army Medical Center — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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