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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04889534
Other study ID # NP380/2013
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2015
Est. completion date January 2017

Study information

Verified date February 2015
Source Instituto do Cancer do Estado de São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1809 patients were evaluated in postoperative period. They were asked about nausea, vomiting, retching and pain in the first postoperative 24 hours


Description:

Patients were prospectively evaluated , and nausea, vomiting and pain were recorded.


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients submitted to oncological surgeries Exclusion Criteria: - refusal to sign the agreement term - lack of information in the records

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Analgesia
Patients will be observed during postoperative period,

Locations

Country Name City State
Brazil Angela Maria Sousa Sao Paulo São Paulo

Sponsors (2)

Lead Sponsor Collaborator
Instituto do Cancer do Estado de São Paulo Sponsor GmbH

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Intensity of postoperative pain pain intensity was measured using descriptive and verbal number scale 24 hours
Secondary side effects from analgesia nausea, vomiting, pruritus and hypotension were measured during first 24 postoperative hours 24 hours
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