- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04489979
Analgetics vs Analgetics and Antibiotics for Pediatric Clinical and Sonographic Orchitis or Epididymitis
August 16, 2021 updated by: Erez Nadir, MD, Hillel Yaffe Medical Center
Some children are admitted to pediatric emergency department due to epididymitis or orchitis.
Some of them are treated by analgetics only whie some are treated by analgetics with antibiotics.
The study will compare clinical presentation between groups and will compare pediatric urologic outpatient clinic follow up findings.
Study Overview
Detailed Description
Some children are admitted to pediatric emergency department due to epididymitis or orchitis.
Some of them are treated by analgetics only whie some are treated by analgetics with antibiotics.
The study will compare clinical presentation between groups and will compare pediatric urologic outpatient clinic follow up findings.
Study Type
Observational
Enrollment (Actual)
72
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
-
-
Hadera
-
H̱adera, Hadera, Israel, 38100
- Hillel Yaffe Medical Center
-
-
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
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Male children who were admitten to pediatric emergency department due to epididymitis or orchitis
Description
Inclusion Criteria:
- All children admitted to pediatric emergency department due to epididymitis or orchitis
Exclusion Criteria:
- No sonographic or laboratory exam
- Antibiotic treatment before diagnosis
- No outpatient follow-up
- Known urologic congenital malformations
- Admission to inpatient department or emergency surgery
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Analgetics only
Children with epididymitis / orchitis treated by analgetics only.
|
Children with epididymitis / orchitis who were treated by antibiotics in addition to analgetics.
|
Analgetics and antibiotics
Children with epididymitis / orchitis treated by analgetics and antibiotics.
|
Children with epididymitis / orchitis who were treated by antibiotics in addition to analgetics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healing
Time Frame: 1 month
|
No symptoms any more
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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 (Actual)
March 1, 2020
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
February 29, 2020
First Submitted That Met QC Criteria
July 27, 2020
First Posted (Actual)
July 28, 2020
Study Record Updates
Last Update Posted (Actual)
August 17, 2021
Last Update Submitted That Met QC Criteria
August 16, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0012-20-HYMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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