Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
80 participants
INTERVENTIONAL
2008-07-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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B
compare caudal anesthesia with bupivacaine alone or in addition to morphine, clonidine or both
Bupivacaine
Caudal anesthesia with bupivacaine 0,166% 1 ml/kg
C
compare caudal anesthesia with bupivacaine plus clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or morphine plus clonidine
Clonidine
1 mcg/kg
M
compare caudal anesthesia with bupivacaine plus morphine with caudal anesthesia with bupivacaine alone or in addition to clonidine or morphine plus clonidine
Morphine
20 mcg/kg
CM
compares caudal anesthesia with bupivacaine, morphine and clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or clonidine
Bupivacaine plus clonidine and morphine
bupivacaine 0,166% 1 ml/kg
clonidine 1 mcg/kg
morphine 20 mcg/kg
Interventions
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Clonidine
1 mcg/kg
Morphine
20 mcg/kg
Bupivacaine plus clonidine and morphine
bupivacaine 0,166% 1 ml/kg
clonidine 1 mcg/kg
morphine 20 mcg/kg
Bupivacaine
Caudal anesthesia with bupivacaine 0,166% 1 ml/kg
Eligibility Criteria
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Inclusion Criteria
* Status physical(ASA) 1 and 2
Exclusion Criteria
1 Year
10 Years
ALL
No
Sponsors
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Santa Casa de Misericórdia de Belo Horizonte
OTHER
Federal University of Minas Gerais
OTHER
Responsible Party
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Federal University of Minas Gerais
Principal Investigators
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Renato S Gomez, PhD, MD
Role: STUDY_DIRECTOR
Federal University of Minas Gerais
Magda L Fernandes, M
Role: PRINCIPAL_INVESTIGATOR
Federal University of Minas Gerais
Locations
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Santa Casa de Belo Horizonte Hospital
Belo Horizonte, Minas Gerais, Brazil
Countries
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References
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Tripi PA, Palmer JS, Thomas S, Elder JS. Clonidine increases duration of bupivacaine caudal analgesia for ureteroneocystostomy: a double-blind prospective trial. J Urol. 2005 Sep;174(3):1081-3. doi: 10.1097/01.ju.0000169138.90628.b9.
Luz G, Innerhofer P, Oswald E, Salner E, Hager J, Sparr H. Comparison of clonidine 1 microgram kg-1 with morphine 30 micrograms kg-1 for post-operative caudal analgesia in children. Eur J Anaesthesiol. 1999 Jan;16(1):42-6. doi: 10.1046/j.1365-2346.1999.00430.x.
Vetter TR, Carvallo D, Johnson JL, Mazurek MS, Presson RG Jr. A comparison of single-dose caudal clonidine, morphine, or hydromorphone combined with ropivacaine in pediatric patients undergoing ureteral reimplantation. Anesth Analg. 2007 Jun;104(6):1356-63, table of contents. doi: 10.1213/01.ane.0000261521.52562.de.
Other Identifiers
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210665
Identifier Type: -
Identifier Source: org_study_id
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