Assessment of Hemodynamic Response in Surgery of Circumcision in Children

NCT00943475 | Completed Phase 4 DMC

• 1 other identifier: CAAE:0101.0.180.000-08
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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®.

Conditions

Children Who Need Circumcision

Keywords

DPNB, pain, hemodynamics effects, circumcision

Outcome Measures

Primary Outcomes (1)

• local anesthesia relieve the circumcision pain

  per-operatory; 1h and 24h pos-operatory

Secondary Outcomes (1)

• local anesthesia relieve the circumcision pos-operatory pain

  1h and 24h pos-operatory

Study Arms (1)

anaesthesia, circumcision

ACTIVE COMPARATOR

Procedure: circumcision

Interventions

circumcision PROCEDURE

circumcision by plastbell

anaesthesia, circumcision

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA status physical 1 children between 3 and 13 years old

You may not qualify if:

• parents don't accept the study classic circumcision

Sponsors & Collaborators

• Federal University of Juiz de Fora: lead

Study Sites (1)

federal University of Juiz de Fora

Juiz de Fora, Minas Gerais, 36036-900, Brazil

Location

Related Publications (2)

• 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.

  PMID: 8010422 RESULT

• 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.

  PMID: 12538184 RESULT

Related Links

• Sociedade Brasileira de Anestesiologia
• Instituto Nacional de Cardiologia / Ministério da Saúde
• Society of Cardiovascular Anesthesia

MeSH Terms

Conditions

Pain

Interventions

Circumcision, Male

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Modification, Non-Therapeutic; Cosmetic Techniques; Therapeutics; Surgical Procedures, Operative; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Jose murillo B Netto, Doctor

  Federal University of Juiz de Fora

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 22, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 22, 2009

Record last verified: 2009-03

Locations

BR (1)