Post-Operative Therapy for Nausea or Vomiting
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|ClinicalTrials.gov Identifier: NCT03075163|
Recruitment Status : Terminated (recruitment futility)
First Posted : March 9, 2017
Results First Posted : June 4, 2019
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Vomiting Nausea||Procedure: Acupressure Drug: Ondansetron||Phase 4|
Each individual will only participate in the post anesthetic care unit starting from when the patient's nurse or anesthesiology team deems that the patient needs treatment for PONV. It ends when the patient is discharged from anesthesiology care.
Patients will be asked to score nausea before randomized treatment of acupressure or medication, and to score nausea after treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimization of Post-Operative Therapy for Nausea or Vomiting|
|Actual Study Start Date :||October 18, 2016|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||December 2018|
Manual pressure will be applied on the wrists bilaterally.
Specifically trained personnel will apply pressure on the wrists bilaterally at the P6 point for up to 3 minutes. The P6 point is located three fingerbreadths from the wrist crease on the volar surface of the arm between the palmaris longus and flexor carpi radialis.
In the event of failure in the acupressure group, further treatments will be identical to the control group. Since Ondansetron is the standard Post Anesthetic Care Unit treatment, it will be first line rescue therapy except in the case that the patient has received 8mg in the past 6 hours. If needed, further antiemetic pharmacologic treatments may include, but are not limited to, phenergan, metoclopramide, haloperidol, diphenhydramine or propofol at the clinical discretion of the patient's anesthesiology care team.
Active Comparator: Ondansetron
Ondansetron (Zofran) is used for the treatment of nausea and vomiting.
Ondansetron is a medication that belongs to the drug class known as antiemetic and selective 5-HT3 receptor antagonist. Ondansetron is prescribed for the treatment of nausea and vomiting due to cancer chemotherapy and also used to prevent and treat nausea and vomiting after surgery.
Other Name: Zofran
- Change in Nausea Score [ Time Frame: Time to discharge from post anesthetic care unit ]
Difference in the nausea score before and after treatment. Nausea is scored on a scale from 1 to 10 with 1 being no nausea and 10 being severe nausea with impending vomiting.
A greater difference is indicative of a better outcome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075163
|United States, California|
|UC Davis Health|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Paul Marc, MD, PhD||University of CA, Davis|
|Principal Investigator:||Neal W Fleming, MD, PhD||University of CA, Davis|