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Trial record 37 of 451 for:    TRAMADOL

Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty

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ClinicalTrials.gov Identifier: NCT01943760
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : September 17, 2013
Sponsor:
Information provided by (Responsible Party):
Ana Laura Albertoni Giraldes, Federal University of São Paulo

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.


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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

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

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



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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943760


Locations
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Brazil
São Paulo Hospital
São Paulo, Brazil, 04023062
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Ana LA Giraldes, MD Federal University of São Paulo

Publications:
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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    Key Record Dates
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:
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Tramadol
Hernia, Inguinal
Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents