Children Who Need CircumcisionPhase 4NCT00943475
Assessment of Hemodynamic Response in Surgery of Circumcision in Children
A Phase 4 study testing circumcision in people with Children Who Need Circumcision, run by Federal University of Juiz de Fora at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 13 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Children Who Need Circumcision
- What is being tested?
- circumcision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 13 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA status physical 1 children between 3 and 13 years old
Who cannot join
- parents don't accept the study classic circumcision
Trial locations and contacts
1 site in 1 country.
Brazil1 site
federal University of Juiz de Fora
Juiz de Fora, Minas Gerais, 36036-900
About this study
Official title: 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®.
- Conditions
- Children Who Need Circumcision
- Being tested
- circumcision
- Keywords
- DPNB, pain, hemodynamics effects, circumcision
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circumcisionProcedure or surgery
circumcision by plastbell
| Study group | Role | What they receive |
|---|---|---|
| anaesthesia, circumcision | Active comparator | Not described Receives: Procedure: circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
local anesthesia relieve the circumcision pain
Measured: per-operatory; 1h and 24h pos-operatory
Secondary outcomes (1)
local anesthesia relieve the circumcision pos-operatory pain
Measured: 1h and 24h pos-operatory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Children Who Need CircumcisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Investigators
- Jose murillo B Netto, Doctor, Principal investigator, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943475
- Sponsor's protocol ID
- CAAE:0101.0.180.000-08
- Status last verified
- Mar 2009
- First submitted
- 21 Jul 2009
- Last updated
- 22 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 8010422Choi 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.
PubMed 12538184
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hemodynamic Response and Pos-operatory Pain in Surgery of Circumcision in Children
- ClinicalTrials.gov ID
- NCT00943475
- Acronym / sponsor ID
- CAAE:0101.0.180.000-08
- Conditions
- Children Who Need Circumcision
- Keywords
- DPNB, pain, hemodynamics effects, circumcision
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anaesthesia, circumcision | Active comparator | Procedure: circumcision |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA status physical 1 children between 3 and 13 years old
Key exclusion criteria (1 listed)
- parents don't accept the study classic circumcision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| circumcisioncircumcision by plastbell | Procedure or surgery | anaesthesia, circumcision |
Primary outcome
local anesthesia relieve the circumcision pain
Time frame: per-operatory; 1h and 24h pos-operatory
1 secondary outcome
local anesthesia relieve the circumcision pos-operatory pain
Time frame: 1h and 24h pos-operatory
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2009.
- Results publication: PubMed 8010422Serour F, Mori J, Barr J. Optimal regional anesthesia for circumcision. Anesth Analg. 1994 Jul;79(1):129-31. doi: 10.1213/00000539-199407000-00024.
- Results publication: PubMed 12538184Choi 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.
- Instituto Nacional de Cardiologia / Ministério da SaúdeLink provided by the sponsor.
- Society of Cardiovascular AnesthesiaLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose murillo B Netto, Doctor principal investigator
Federal University of Juiz de Fora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing circumcision in people with Children Who Need Circumcision, run by Federal University of Juiz de Fora at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local anesthesia relieve the circumcision pain (time frame: per-operatory; 1h and 24h pos-operatory). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00943475, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2009.