Clinical trial NCT01943760: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Children
Inguinal Hernia
Keywords: Tramadol
Children
Hernioplasty
Wound infiltration
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain intensity after wound infiltration with tramadol
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: São Paulo Hospital
Study officials:
affiliation: Federal University of São Paulo
name: Ana LA Giraldes, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.