Children Who Need Circumcision Clinical Trial
Official title:
Assessment of Hemodynamic Response and Pos-operatory Pain in Surgery of Circumcision in Children
| Verified date | March 2009 |
| Source | Federal University of Juiz de Fora |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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®.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | June 2009 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 3 Years to 13 Years |
| Eligibility |
Inclusion Criteria: ASA status physical 1 children between 3 and 13 years old Exclusion Criteria: - parents don't accept the study classic circumcision |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | federal University of Juiz de Fora | Juiz de Fora | Minas gerais |
| Lead Sponsor | Collaborator |
|---|---|
| Federal University of Juiz de Fora |
Brazil,
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. — View Citation
Serour F, Mori J, Barr J. Optimal regional anesthesia for circumcision. Anesth Analg. 1994 Jul;79(1):129-31. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | local anesthesia relieve the circumcision pain | per-operatory; 1h and 24h pos-operatory | ||
| Secondary | local anesthesia relieve the circumcision pos-operatory pain | 1h and 24h pos-operatory |