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PainPhase 3NCT00480519

Use of Sedation and Local Anesthesia in Meatotomy: A Prospective Comparison Study

A Phase 3 study testing Meatotomy in people with Pain, run by Rabin Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 3 to 18 years, men only
Conditions the study is for
Pain
What is being tested?
Meatotomy
Type of treatment
Surgery or procedure
How many people
75 participants
Where
1 siteIsrael
Study dates
May 2007to May 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 18 years
  • Men only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • ASA grade > 2

Trial locations and contacts

1 site in 1 country.

David Ben-Meir, MD contact

972526903043

Davidbm@clalit.org.il

Rachel Efrat, MD contact

972504057137

pedpain@clalit.org.il

Israel1 site, 1 recruiting
  • Schneider Children's Medical Center of Israel

    Petah Tikva

    David Ben-Meir, MD, 09752903043, davidbm@clalit.org.il

    Rachel Efrat, MD, 972504057137, pedpain@clalit.org.il

    Recruiting

Other trials in Israel

About this study

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

Read the detailed description

Background- Meatal stenosis requiring surgery occurs more often in circumcised than in uncircumcised boys, with an estimated rate of 7.3%. At our institute, meatotomy is usually performed under general anesthesia and penile block is routinely added after induction. Recently, several reports have described the performance of meatotomy as an office procedure under local anesthesia, with good patient tolerability and a considerable reduction in operative time and costs.

Purpose - 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.

Materials and Methods- The study population will include 75 otherwise healthy boys aged 3 years to 15 years scheduled for meatotomy at our institute. Children with ASA grade >2 will be excluded. The children will be reexamined by a senior pediatric ulologist to confirm the need for surgery. All children and their parents will be given a detailed explanation of the procedure and of the anesthesia and pain control options available by a urology nurse, pediatric urologist, and anesthesist.

Prior to surgery, study participants will be randomly allocated to one of the following groups:

Group 1 will include 25 patients who will undergo meatotomy under sedation and local anesthesia. The penis will be topically treated with EMLA cream one hour before surgery and then covered with tegaderm. In children aged 3-5 years, sedation will consist of midazolam 0.5 mg/kg (up to 10 mgs) p.o., administered 20 minutes before surgery; children aged 5 years and older will receive nitrous oxide (up to 60%) with oxygen. All patients will be connected to a pulse oximeter and monitored by a sedation nurse or an anesthesist.

Group 2 will include 25 boys operated on under general anaesthesia. Anesthesia will be induced by Sevoflurane 8% or IV propofol 2 mg/kg and maintained with sevoflurane 3% or isoflurane 1% and nitrous oxide. Ropivacaine 0.2% 1 cc-5 cc will be administered for penile block following induction.

Group 3 will include 25 boys operated on under general anesthesia, like group 2, but without penile block.

All children in all groups will receive paracetamol 15 mg/kg (up 500 mg) as suppository or suspension after completion of the meatotomy, and will be monitored by a sedation nurse until they are fully recovered. They will be discharged from the hospital after a successful spontaneous void.

Prior to patient discharge, the parents will be asked to complete a form grading their child's current pain level and their general satisfaction with the procedure (Appendix I). Boys older than 5 years will be asked to complete their own pain scale as well.

Twenty-four hours after surgery, the parents will be asked, by telephone, to again grade their child's current pain; to report the type and doses of pain medications used within this time frame, to score their child's voiding quality; and to rate their general satisfaction (Appendix II).

All patients will be invited for a follow-up visit at the clinic one month after the procedure. At that time, a urologist will assess the meatal width and voiding quality (Appendix III).

Conditions
Pain
Being tested
Meatotomy
Keywords
meatotomy, meatal stenosis, local anaesthesia, feasibility, pain control
Medical subject headings
Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MeatotomyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain control, voiding quality

    Measured: one month after the procedure

Secondary outcomes (1)
  1. general satisfaction

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2007 (estimated)
  2. Study startMay 2007
  3. Study completionMay 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00480519
Sponsor's protocol ID
scmc4304ctil
Status last verified
May 2007
First submitted
30 May 2007
Last updated
31 May 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meatotomy in people with Pain, run by Rabin Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 May 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact David Ben-Meir, MD (972526903043, Davidbm@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain control, voiding quality (time frame: one month after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2007.

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