Analgetics vs Analgetics and Antibiotics for Pediatric Clinical and Sonographic Orchitis or Epididymitis

• Sponsor: Hillel Yaffe Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04489979
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Actual Duration (Months): 10
• Patients Per Site Per Month: 7.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Epididymitis Orchitis	Other: Antibiotics

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 Design

• Study Type: Observational
• Actual Enrollment: 72 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Analgetics vs Analgetics and Antibiotics for Pediatric Clinical and Sonographic Orchitis or Epididymitis
• Actual Study Start Date: Mar 1, 2020
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Analgetics only Children with epididymitis / orchitis treated by analgetics only.	Other: Antibiotics; 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.	Other: Antibiotics; Children with epididymitis / orchitis who were treated by antibiotics in addition to analgetics.

Outcome Measures

Primary Outcome Measures

1. Healing [1 month]

   No symptoms any more

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hillel Yaffe medical center	H̱adera	Hadera	Israel	38100

Sponsors and Collaborators

• Hillel Yaffe Medical Center

Investigators

• Principal Investigator: Erez Nadir, MD, Hillel Yaffe Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• Lau P, Anderson PA, Giacomantonio JM, Schwarz RD. Acute epididymitis in boys: are antibiotics indicated? Br J Urol. 1997 May;79(5):797-800.

• Responsible Party: Erez Nadir, MD, Neonatologist, Hillel Yaffe Medical Center
• ClinicalTrials.gov Identifier: NCT04489979
• Other Study ID Numbers: 0012-20-HYMC
• First Posted: Jul 28, 2020
• Last Update Posted: Aug 17, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Orchitis; Epididymitis; Anti-Bacterial Agents

Study Results

No Results Posted as of Aug 17, 2021