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

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.

Condition or disease	Intervention/treatment	Phase
Children; Inguinal Hernia	Drug: tramadol; Drug: 0.9% saline	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Analgesic Effect of Tramadol Wound Infiltration in Children Under Inguinal Hernioplasty. A Double-blind, Randomized Study.
• Study Start Date: September 2012
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: September 2013

Arms and Interventions

Arm	Intervention/treatment
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	Drug: tramadol; The volume of the solution was adequate to maintain the concentration of 2% tramadol; Other Name: tramal; 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	Drug: tramadol; The volume of the solution was adequate to maintain the concentration of 2% tramadol; Other Name: tramal; Drug: 0.9% saline

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Brazil

São Paulo Hospital

São Paulo, Brazil, 04023062

Sponsors and Collaborators

Federal University of São Paulo

Investigators

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

More Information

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.

• Responsible Party: Ana Laura Albertoni Giraldes, doctor, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT01943760 History of Changes
• Other Study ID Numbers: 187177
• First Posted: September 17, 2013
• Last Update Posted: September 17, 2013
• Last Verified: September 2013

Keywords provided by Ana Laura Albertoni Giraldes, Federal University of São Paulo:

Tramadol; Children; Hernioplasty; Wound infiltration

Additional relevant MeSH terms:

Hernia, Inguinal; Hernia; Pathological Conditions, Anatomical; Hernia, Abdominal; Tramadol; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents