Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty

Status Completed

Clinical Trial 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 Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01943760
Study type	Interventional
Source	Federal University of São Paulo
Contact
Status	Completed
Phase	Phase 4
Start date	September 2012
Completion date	September 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03563196` - Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
Completed	`NCT02553486` - Internationally Adopted Children Quality of Life	N/A
Completed	`NCT02903134` - Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity
Completed	`NCT02918890` - Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia	N/A
Active, not recruiting	`NCT01874847` - PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin	Phase 2/Phase 3
Enrolling by invitation	`NCT01971840` - Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period.	N/A
Enrolling by invitation	`NCT01971827` - Effectiveness of a Physical Activity Intervention to Prevent Obesity and Improve Academic Performance	N/A
Completed	`NCT01738308` - The Effects of Healing Touch on Post Operative Pediatric Patients	N/A
Completed	`NCT01864811` - Effect of Baby-CIMT in Infants Younger Than 12 Months	N/A
Completed	`NCT01693926` - Effect of Physical Activity an Stress in Children	N/A
Completed	`NCT01323010` - Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes	N/A
Completed	`NCT01277224` - Effectiveness of a Physical Activity Intervention on the Obesity of Schoolchildren	N/A
Active, not recruiting	`NCT00989547` - Cord Blood Infusion for Type 1 Diabetes Mellitus (T1DM)	Phase 1
Completed	`NCT04051723` - Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-Craniotomy Pain in Children	Phase 4
Completed	`NCT03236363` - Effectiveness of MOVI Interventions on Adiposity, Cognition and Motor Competence: MOVI-da10!	N/A
Completed	`NCT03236337` - Effectiveness of MOVI Interventions on Adiposity, Cognition and Subclinical Atherosclerosis: MOVI-daFit!	N/A
Not yet recruiting	`NCT03427697` - Effect of VR and Accommdation Relax on Controlling Myopia in Children	N/A
Completed	`NCT05603507` - Inspiratory Muscle Training in Children With Chest Burn	N/A
Not yet recruiting	`NCT06267339` - Effects of Transcranial Random Noise Stimulation on Motor Learning in Typically Developing Adolescents	Early Phase 1
Recruiting	`NCT04608968` - Pediatric Perioperative Satisfaction Questionnaire

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.