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

July 21, 2009
July 21, 2009
March 2009
March 2009   (final data collection date for primary outcome measure)
local anesthesia relieve the circumcision pain [ Time Frame: per-operatory; 1h and 24h pos-operatory ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
local anesthesia relieve the circumcision pos-operatory pain [ Time Frame: 1h and 24h pos-operatory ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Assessment of Hemodynamic Response in Surgery of Circumcision in Children
Assessment of Hemodynamic Response and Pos-operatory Pain 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®.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Children Who Need Circumcision
Procedure: circumcision
circumcision by plastbell
Active Comparator: anaesthesia, circumcision
Intervention: Procedure: circumcision

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

ASA status physical 1 children between 3 and 13 years old

Exclusion Criteria:

  • parents don't accept the study classic circumcision
Male
3 Years to 13 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00943475
CAAE:0101.0.180.000-08
Yes
Marcello Fonseca Salgado Filho, Federal University of Juiz de Fora
Federal University of Juiz de Fora
Not Provided
Principal Investigator: Jose murillo B Netto, Doctor Federal University of Juiz de Fora
Federal University of Juiz de Fora
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP