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Assessment of Hemodynamic Response in Surgery of Circumcision in Children

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00943475
Enrollment
40
Registered
2009-07-22
Start date
2009-03-31
Completion date
2009-06-30
Last updated
2009-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children Who Need Circumcision

Keywords

DPNB, pain, hemodynamics effects, circumcision

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®.

Interventions

PROCEDUREcircumcision

circumcision by plastbell

Sponsors

Federal University of Juiz de Fora
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
3 Years to 13 Years
Healthy volunteers
Yes

Inclusion criteria

ASA status physical 1 children between 3 and 13 years old

Exclusion criteria

* parents don't accept the study classic circumcision

Design outcomes

Primary

MeasureTime frame
local anesthesia relieve the circumcision painper-operatory; 1h and 24h pos-operatory

Secondary

MeasureTime frame
local anesthesia relieve the circumcision pos-operatory pain1h and 24h pos-operatory

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026