Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty
Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Children; Inguinal Hernia
Intervention: tramadol (Drug); 0.9% saline (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Federal University of São Paulo Official(s) and/or principal investigator(s): Ana LA Giraldes, MD, Principal Investigator, Affiliation: Federal University of São Paulo
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.
Clinical Details
Official title: Evaluation of the Analgesic Effect of Tramadol Wound Infiltration in Children Under Inguinal Hernioplasty. A Double-blind, Randomized Study.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Pain intensity after wound infiltration with tramadol
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
Minimum age: 3 Years.
Maximum age: 12 Years.
Gender(s): Both.
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.
Locations and Contacts
São Paulo Hospital, São Paulo 04023062, Brazil
Additional Information
Related 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.
Starting date: September 2012
Last updated: September 16, 2013
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