N/A
N=28
Ondansetron and the QT Interval In Adult Emergency Department Patients
Ondansetron
Bottom Line
View on ClinicalTrials.gov: NCT01759420 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Change in QTc Interval With Ondansetron Administration — 19.7 mS
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Ondansetron (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- C.R.Darnall Army Medical Center
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in QTc Interval With Ondansetron Administration |
19.7 | — |
| SECONDARY Number of Adverse Events |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age >18
- Patient to receive 4mg of intravenous ondansetron
Exclusion Criteria
- Age 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
Data sourced from ClinicalTrials.gov (NCT01759420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.