- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04889534
Predictive Factors for Postoperative Pain, Nausea and Vomiting in Oncological Patients (PONV)
May 14, 2021 updated by: Instituto do Cancer do Estado de São Paulo
Evaluation of Predictive Factors for Nausea, Vomiting and Postoperative Acute Pain in Oncological Patients
1809 patients were evaluated in postoperative period.
They were asked about nausea, vomiting, retching and pain in the first postoperative 24 hours
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients were prospectively evaluated , and nausea, vomiting and pain were recorded.
Study Type
Observational
Enrollment (Actual)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Sao Paulo, São Paulo, Brazil, 01403010
- Angela Maria Sousa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients submitted to oncological surgeries in a specialized Hospital
Description
Inclusion Criteria:
- patients submitted to oncological surgeries
Exclusion Criteria:
- refusal to sign the agreement term
- lack of information in the records
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intensity of postoperative pain
Time Frame: 24 hours
|
pain intensity was measured using descriptive and verbal number scale
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
side effects from analgesia
Time Frame: 24 hours
|
nausea, vomiting, pruritus and hypotension were measured during first 24 postoperative hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Hazem A Ashmawi, phD, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gramke HF, de Rijke JM, van Kleef M, Kessels AG, Peters ML, Sommer M, Marcus MA. Predictive factors of postoperative pain after day-case surgery. Clin J Pain. 2009 Jul-Aug;25(6):455-60. doi: 10.1097/AJP.0b013e31819a6e34.
- Lee SY, Hung CJ, Chen CC, Wu CC. Survival analysis of postoperative nausea and vomiting in patients receiving patient-controlled epidural analgesia. J Chin Med Assoc. 2014 Nov;77(11):589-93. doi: 10.1016/j.jcma.2014.08.008. Epub 2014 Sep 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
August 9, 2018
First Submitted That Met QC Criteria
May 14, 2021
First Posted (Actual)
May 17, 2021
Study Record Updates
Last Update Posted (Actual)
May 17, 2021
Last Update Submitted That Met QC Criteria
May 14, 2021
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NP380/2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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