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Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty

Evaluation of the Analgesic Effect of Tramadol Wound Infiltration in Children Under Inguinal Hernioplasty. A Double-blind, Randomized Study.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01943760
Enrollment
40
Registered
2013-09-17
Start date
2012-09-30
Completion date
2013-09-30
Last updated
2013-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Inguinal Hernia

Keywords

Tramadol, Children, Hernioplasty, Wound infiltration

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.

Interventions

DRUGtramadol

The volume of the solution was adequate to maintain the concentration of 2% tramadol

DRUG0.9% saline

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity after wound infiltration with tramadol1 monthFaces scale

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026