Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty

NCT01943760 | Completed Phase 4

• 1 other identifier: 187177
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Children; Inguinal Hernia

Keywords

Tramadol; Children; Hernioplasty; Wound infiltration

Outcome Measures

Primary Outcomes (1)

• Pain intensity after wound infiltration with tramadol

  Faces scale

  1 month

Study Arms (2)

tramadol wound infiltration

ACTIVE COMPARATOR

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; Drug: 0.9% saline

tramadol intravenous administration

EXPERIMENTAL

2 mg / kg of tramadol diluted 20ml of 0.9% saline solution intravenously 5 ml of 0.9% saline solution wound infiltration

Drug: tramadol; Drug: 0.9% saline

Interventions

tramadol DRUG

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

Also known as: tramal

tramadol intravenous administration; tramadol wound infiltration

0.9% saline DRUG

tramadol intravenous administration; tramadol wound infiltration

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children of both sexes
• aged between 3 and 12 years
• underwent hernioplasty

You may not qualify if:

• children with bleeding disorders
• using analgesic
• sensitivity to any drug.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

São Paulo Hospital

São Paulo, São Paulo, 04023062, Brazil

Location

Related Publications (1)

• 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.

  PMID: 16972834 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Tramadol; Saline Solution

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ana LA Giraldes, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 17, 2013
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

BR (1)