- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00943475
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®.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Minas gerais
-
Juiz de Fora, Minas gerais, Brazil, 36036-900
- Federal University of Juiz de Fora
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
ASA status physical 1 children between 3 and 13 years old
Exclusion Criteria:
- parents don't accept the study classic circumcision
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: anaesthesia, circumcision
|
circumcision by plastbell
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
local anesthesia relieve the circumcision pain
Time Frame: per-operatory; 1h and 24h pos-operatory
|
per-operatory; 1h and 24h pos-operatory
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
local anesthesia relieve the circumcision pos-operatory pain
Time Frame: 1h and 24h pos-operatory
|
1h and 24h pos-operatory
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jose murillo B Netto, Doctor, Federal University of Juiz de Fora
Publications and helpful links
General Publications
- Serour F, Mori J, Barr J. Optimal regional anesthesia for circumcision. Anesth Analg. 1994 Jul;79(1):129-31. doi: 10.1213/00000539-199407000-00024.
- Choi WY, Irwin MG, Hui TW, Lim HH, Chan KL. EMLA cream versus dorsal penile nerve block for postcircumcision analgesia in children. Anesth Analg. 2003 Feb;96(2):396-9, table of contents. doi: 10.1097/00000539-200302000-00018.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CAAE:0101.0.180.000-08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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