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Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty

Primary Purpose

Children, Inguinal Hernia

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
tramadol
0.9% saline
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Children focused on measuring Tramadol, Children, Hernioplasty, Wound infiltration

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • children of both sexes
  • aged between 3 and 12 years
  • underwent hernioplasty

Exclusion Criteria:

  • children with bleeding disorders
  • using analgesic
  • sensitivity to any drug.

Sites / Locations

  • São Paulo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

tramadol wound infiltration

tramadol intravenous administration

Arm Description

2 mg / kg of tramadol diluted in 5 ml of 0.9% saline solution wound infiltration 20ml of 0.9% saline solution intravenously

2 mg / kg of tramadol diluted 20ml of 0.9% saline solution intravenously 5 ml of 0.9% saline solution wound infiltration

Outcomes

Primary Outcome Measures

Pain intensity after wound infiltration with tramadol
Faces scale

Secondary Outcome Measures

Full Information

First Posted
September 9, 2013
Last Updated
September 16, 2013
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01943760
Brief Title
Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty
Official Title
Evaluation of the Analgesic Effect of Tramadol Wound Infiltration in Children Under Inguinal Hernioplasty. A Double-blind, Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Tramadol is a centrally acting analgesic, is primarily Indicated for the treatment of acute pain, moderate to severe. The hernioplasty in children is an outpatient procedure, and the possibility of postoperative analgesia with fewer systemic adverse effects such as nausea and vomiting make the tramadol infiltration a technique of interest. There is controversy about its effectiveness. 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
The primary objective of the study was to evaluate the analgesic effect of tramadol injected into the surgical incision in patients undergoing hernioplasty. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children, Inguinal Hernia
Keywords
Tramadol, Children, Hernioplasty, Wound infiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tramadol wound infiltration
Arm Type
Active Comparator
Arm Description
2 mg / kg of tramadol diluted in 5 ml of 0.9% saline solution wound infiltration 20ml of 0.9% saline solution intravenously
Arm Title
tramadol intravenous administration
Arm Type
Experimental
Arm Description
2 mg / kg of tramadol diluted 20ml of 0.9% saline solution intravenously 5 ml of 0.9% saline solution wound infiltration
Intervention Type
Drug
Intervention Name(s)
tramadol
Other Intervention Name(s)
tramal
Intervention Description
The volume of the solution was adequate to maintain the concentration of 2% tramadol
Intervention Type
Drug
Intervention Name(s)
0.9% saline
Primary Outcome Measure Information:
Title
Pain intensity after wound infiltration with tramadol
Description
Faces scale
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: children of both sexes aged between 3 and 12 years underwent hernioplasty Exclusion Criteria: children with bleeding disorders using analgesic sensitivity to any drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana LA Giraldes, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
São Paulo Hospital
City
São Paulo
ZIP/Postal Code
04023062
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
16972834
Citation
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.
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Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty

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