Assessment of Hemodynamic Response in Surgery of Circumcision in Children

This study has been completed.
Sponsor:
Information provided by:
Federal University of Juiz de Fora
ClinicalTrials.gov Identifier:
NCT00943475
First received: July 21, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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®.


Condition Intervention Phase
Children Who Need Circumcision
Procedure: circumcision
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Hemodynamic Response and Pos-operatory Pain in Surgery of Circumcision in Children

Resource links provided by NLM:


Further study details as provided by Federal University of Juiz de Fora:

Primary Outcome Measures:
  • local anesthesia relieve the circumcision pain [ Time Frame: per-operatory; 1h and 24h pos-operatory ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • local anesthesia relieve the circumcision pos-operatory pain [ Time Frame: 1h and 24h pos-operatory ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: anaesthesia, circumcision Procedure: circumcision
circumcision by plastbell

  Eligibility

Ages Eligible for Study:   3 Years to 13 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

ASA status physical 1 children between 3 and 13 years old

Exclusion Criteria:

  • parents don't accept the study classic circumcision
  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: NCT00943475

Locations
Brazil
federal University of Juiz de Fora
Juiz de Fora, Minas gerais, Brazil, 36036-900
Sponsors and Collaborators
Federal University of Juiz de Fora
Investigators
Principal Investigator: Jose murillo B Netto, Doctor Federal University of Juiz de Fora
  More Information

Additional Information:
pubmed  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Marcello Fonseca Salgado Filho, Federal University of Juiz de Fora
ClinicalTrials.gov Identifier: NCT00943475     History of Changes
Other Study ID Numbers: CAAE:0101.0.180.000-08
Study First Received: July 21, 2009
Last Updated: July 21, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Juiz de Fora:
DPNB, pain, hemodynamics effects, circumcision

ClinicalTrials.gov processed this record on October 19, 2014