Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty
NCT ID: NCT01943760
Last Updated: 2013-09-17
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
PHASE4
40 participants
INTERVENTIONAL
2012-09-30
2013-09-30
Brief Summary
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The local effect of tramadol in hernioplasty was also studied by researchers with some better postoperative analgesia than with local anestetic .
There are few studies with administration of tramadol for hernioplasty, Which led to the interest in this study.
Detailed Description
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The study is a prospective, comparative, double covered. The distribution of patients in the groups was randomly drawn prior to starting the project and the groups were identified in envelopes numbered 1-40.
Criteria for inclusion and exclusion After approval by the Ethics Committee of UNIFESP and signature of consent by those responsible, and the term of assent by patients over six years, 40 children of both sexes will be evaluated, aged between 3 and 12 years who underwent hernioplasty.
Children with bleeding disorders, using analgesic or sensitivity to any drug will be excluded.
The patients will be randomly divided into one of two groups. Patients in group 1 will receive local infiltration with 2 mg / kg of tramadol diluted in 5 ml of 0.9% saline solution and 20ml of 0.9% saline solution intravenously at the end of the surgical procedure Patients in group 2 will receive 2 mg.kg-1 tramadol intravenously diluted in 20 ml of 0.9% saline solution and local infiltration with 5 mL of saline solution 0.9% at the end of the surgical procedure.
All patients will undergo general anesthesia, and will receive additional analgesia with dipyrone and morphine as needed in post operative period.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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tramadol wound infiltration
2 mg / kg of tramadol diluted in 5 ml of 0.9% saline solution wound infiltration 20ml of 0.9% saline solution intravenously
tramadol
The volume of the solution was adequate to maintain the concentration of 2% tramadol
0.9% saline
tramadol intravenous administration
2 mg / kg of tramadol diluted 20ml of 0.9% saline solution intravenously 5 ml of 0.9% saline solution wound infiltration
tramadol
The volume of the solution was adequate to maintain the concentration of 2% tramadol
0.9% saline
Interventions
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tramadol
The volume of the solution was adequate to maintain the concentration of 2% tramadol
0.9% saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged between 3 and 12 years
* underwent hernioplasty
Exclusion Criteria
* using analgesic
* sensitivity to any drug.
3 Years
12 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Ana Laura Albertoni Giraldes
doctor
Principal Investigators
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Ana LA Giraldes, MD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Locations
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São Paulo Hospital
São Paulo, São Paulo, Brazil
Countries
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References
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Demiraran Y, Ilce Z, Kocaman B, Bozkurt P. Does tramadol wound infiltration offer an advantage over bupivacaine for postoperative analgesia in children following herniotomy? Paediatr Anaesth. 2006 Oct;16(10):1047-50. doi: 10.1111/j.1460-9592.2006.01910.x.
Other Identifiers
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187177
Identifier Type: -
Identifier Source: org_study_id