Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty

• ClinicalTrials.gov Identifier: NCT01943760
• Recruitment Status: Completed
• First Posted: September 17, 2013
• Last Update Posted: September 17, 2013
• Sponsor: Federal University of São Paulo
• Information provided by (Responsible Party): Ana Laura Albertoni Giraldes, Federal University of São Paulo

Tracking Information

• First Submitted Date: September 9, 2013
• First Posted Date: September 17, 2013
• Last Update Posted Date: September 17, 2013
• Study Start Date: September 2012
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 16, 2013)

Pain intensity after wound infiltration with tramadol [ Time Frame: 1 month ]

Faces scale

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.

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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Children
• Inguinal Hernia

Intervention

• Drug: tramadol
  The volume of the solution was adequate to maintain the concentration of 2% tramadol
  Other Name: tramal
• Drug: 0.9% saline

Study Arms

• Active Comparator: 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
  Interventions:

  • Drug: tramadol
  • Drug: 0.9% saline
• Experimental: 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
  Interventions:

  • Drug: tramadol
  • Drug: 0.9% saline

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 16, 2013): 40
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2013
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01943760
• Other Study ID Numbers: 187177
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ana Laura Albertoni Giraldes, Federal University of São Paulo
• Study Sponsor: Federal University of São Paulo
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ana LA Giraldes, MD; Federal University of São Paulo

• PRS Account: Federal University of São Paulo
• Verification Date: September 2013