Assessment of Hemodynamic Response in Surgery of Circumcision in Children

NCT ID: NCT00943475

Last Updated: 2009-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-06-30

Brief Summary

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The surgery stress relives systemic inflammatory response by hormones and adrenergic receptors. When the pro-inflammatory mediator is higher than anti-inflammatory response, the physiologic status is impaired and the patient is more susceptible an infection and cardiovascular collapse. The anesthesia can abolish or minimize the surgery stress, improved more safety to the patient.

This study is a double blind controlled trial with 40 patients divided in two groups (EMLA and Dorsal Penile Nerve Block - DPNB) submitted a standard inhalator anesthesia and postectomy surgery by Plastbell®. The investigators will be observe heart rate, respiratory rate, arterial pressure, involuntary movements during the surgery and pain in the pos-operatory.

With this study, the investigators can define what tactic (EMLA or DPNB) associated a general anesthesia is more effective to relive the pain when children are submitted a postectomy by Plastbell®.

Detailed Description

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Conditions

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Children Who Need Circumcision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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anaesthesia, circumcision

Group Type ACTIVE_COMPARATOR

circumcision

Intervention Type PROCEDURE

circumcision by plastbell

Interventions

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circumcision

circumcision by plastbell

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

ASA status physical 1 children between 3 and 13 years old

Exclusion Criteria

* parents don't accept the study classic circumcision
Minimum Eligible Age

3 Years

Maximum Eligible Age

13 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Juiz de Fora

OTHER

Sponsor Role lead

Responsible Party

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Federal University of Juiz de Fora

Principal Investigators

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Jose murillo B Netto, Doctor

Role: PRINCIPAL_INVESTIGATOR

Federal University of Juiz de Fora

Locations

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federal University of Juiz de Fora

Juiz de Fora, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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Serour F, Mori J, Barr J. Optimal regional anesthesia for circumcision. Anesth Analg. 1994 Jul;79(1):129-31. doi: 10.1213/00000539-199407000-00024.

Reference Type RESULT
PMID: 8010422 (View on PubMed)

Choi WY, Irwin MG, Hui TW, Lim HH, Chan KL. EMLA cream versus dorsal penile nerve block for postcircumcision analgesia in children. Anesth Analg. 2003 Feb;96(2):396-9, table of contents. doi: 10.1097/00000539-200302000-00018.

Reference Type RESULT
PMID: 12538184 (View on PubMed)

Related Links

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http://www.sba.com.br

Sociedade Brasileira de Anestesiologia

http://www.inc.saude.gov.br

Instituto Nacional de Cardiologia / Ministério da Saúde

http://www.scahq.org

Society of Cardiovascular Anesthesia

Other Identifiers

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CAAE:0101.0.180.000-08

Identifier Type: -

Identifier Source: org_study_id

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