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Completed

NCT Number: NCT00943475

Assessment of Hemodynamic Response in Surgery of Circumcision in Children

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®.

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Key information

Conditions

Children Who Need Circumcision Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–13 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

federal University of Juiz de Fora

Juiz de Fora, Minas Gerais, 36036-900, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ASA status physical 1 children between 3 and 13 years old

Exclusion criteria

  • parents don't accept the study classic circumcision

Treatment and study plan

Circumcision

Procedure

circumcision by plastbell

Primary outcomes

  1. local anesthesia relieve the circumcision pain

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

Secondary outcomes

  1. local anesthesia relieve the circumcision pos-operatory pain

    Time frame: 1h and 24h pos-operatory

Sponsors and collaborators

Lead sponsor

Federal University of Juiz de Fora

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 22, 2009
Registry last updated
Jul 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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