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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00480519
• Other study ID #: scmc4304ctil
• Status: Recruiting
• Phase: Phase 3
• First received: May 30, 2007
• Last updated: May 30, 2007
• Start date: May 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2007
• Source: Rabin Medical Center
• Contact: David Ben-Meir, MD
• Phone: 972526903043
• Email: Davidbm[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• ASA grade > 2

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Meatotomy

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petah Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Schneider Children's Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain control, voiding quality		one month after the procedure
Secondary	general satisfaction		before the child is discharged from the hospital, and one month after the procedure