NCT00480519

Brief Summary

The aim of the study is to prospectively investigate the feasibility, pain control, and outcome of meatotomy performed under sedation and local anaesthesia compared with general anaesthesia with and without patient block

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 31, 2007

Status Verified

May 1, 2007

First QC Date

May 30, 2007

Last Update Submit

May 30, 2007

Conditions

Pain

Keywords

meatotomymeatal stenosislocal anaesthesiafeasibilitypain control

Outcome Measures

Primary Outcomes (1)

  • pain control, voiding quality

    one month after the procedure

Secondary Outcomes (1)

  • general satisfaction

    before the child is discharged from the hospital, and one month after the procedure

Interventions

MeatotomyPROCEDURE

Eligibility Criteria

Age3 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Boys between 3 years and 18 years with meatal stenosis requiring meatotomy

You may not qualify if:

  • ASA grade \> 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

PainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • David Ben-Meir, MD

    Schneider Chlidren's medical Center of Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Ben-Meir, MD

CONTACT

972526903043Davidbm@clalit.org.il

Rachel Efrat, MD

CONTACT

972504057137pedpain@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2007

First Posted

May 31, 2007

Study Start

May 1, 2007

Study Completion

May 1, 2008

Last Updated

May 31, 2007

Record last verified: 2007-05

Locations

IL(1)