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Clinical Trials/NCT00943475
NCT00943475
Completed
Phase 4

Assessment of Hemodynamic Response and Pos-operatory Pain in Surgery of Circumcision in Children

Federal University of Juiz de Fora1 site in 1 country40 target enrollmentMarch 2009

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Children Who Need Circumcision
Sponsor
Federal University of Juiz de Fora
Enrollment
40
Locations
1
Primary Endpoint
local anesthesia relieve the circumcision pain
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

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®.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
June 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Federal University of Juiz de Fora

Eligibility Criteria

Inclusion Criteria

  • ASA status physical 1 children between 3 and 13 years old

Exclusion Criteria

  • parents don't accept the study classic circumcision

Outcomes

Primary Outcomes

local anesthesia relieve the circumcision pain

Time Frame: per-operatory; 1h and 24h pos-operatory

Secondary Outcomes

  • local anesthesia relieve the circumcision pos-operatory pain(1h and 24h pos-operatory)

Study Sites (1)

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