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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Rabin Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Schneider Children's Hospital
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00480519
First received: May 30, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  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


Condition Intervention Phase
Pain
Procedure: Meatotomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Use of Sedation and Local Anesthesia in Meatotomy: A Prospective Comparison Study

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • pain control, voiding quality [ Time Frame: one month after the procedure ]

Secondary Outcome Measures:
  • general satisfaction [ Time Frame: before the child is discharged from the hospital, and one month after the procedure ]

Estimated Enrollment: 75
Study Start Date: May 2007
Estimated Study Completion Date: May 2008
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).

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • ASA grade > 2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480519

Contacts
Contact: David Ben-Meir, MD 972526903043 Davidbm@clalit.org.il
Contact: Rachel Efrat, MD 972504057137 pedpain@clalit.org.il

Locations
Israel
Schneider Children's Medical Center of Israel Recruiting
Petah Tikva, Israel
Contact: David Ben-Meir, MD    09752903043    davidbm@clalit.org.il   
Contact: Rachel Efrat, MD    972504057137    pedpain@clalit.org.il   
Principal Investigator: David Ben-Meir, MD         
Sponsors and Collaborators
Rabin Medical Center
Schneider Children's Hospital
Investigators
Principal Investigator: David Ben-Meir, MD Schneider Chlidren's medical Center of Israel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00480519     History of Changes
Other Study ID Numbers: scmc4304ctil
Study First Received: May 30, 2007
Last Updated: May 30, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
meatotomy
meatal stenosis
local anaesthesia
feasibility
pain control

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014