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Comparison of Peritonsillar Infiltration of Tramadol Ketamine and Placebo on Pediatric Posttonsillectomy Pain

NCT03067103 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2017-05-03

No results posted yet for this study

Summary

Adenotonsillectomy is one of the most common ambulatory surgical procedures performed to children. Tonsillectomy or adenotonsillectomy have a high incidence of postoperative pain. There is still debate about the optimal analgesia for this common surgical procedure. Different methods have been described and used to reduce pain including; improved intraoperative anesthetic pain regimens, use of corticosteroids, adjustment of surgical technique, and intraoperative local anesthetic injection. Intraoperative local anesthetic is a preventive or preemptive analgesia which is the analgesia given before painful stimuli to prevent the subsequent pain. The main goal of the preventive analgesia is the pain relief with minimum side effects. The role of local anesthetic infiltration in the reduction of postadenotonsillectomy pain is still controversial. The objective of this study is to investigate and compare the effectiveness of preincisional peritonsillar infiltration of ketamine and tramadol for post-operative pain on children following adenotonsillectomy. This is prospective, double-blinded randomized study.

Conditions

  • Sleep Disorder; Breathing-Related
  • Pain, Postoperative
  • Child, Only

Interventions

DRUG

Tramadol

Patients will receive injections in peritonsillar fossa of tramadol (2 mg/kg-2 ml)

DRUG

Ketamine

Patients will receive injections in peritonsillar fossa of ketamine prior to surgery

DRUG

Placebos

Patients will receive 2mL of saline solution in peritonsillar fossa prior to surgery

Sponsors & Collaborators

  • Universidade Federal de Goias

    lead OTHER

Principal Investigators

  • juliana a caixeta, MD · Assistant Doctor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
3 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2017-07-01
Completion
2019-05-01

Countries

  • Brazil

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03067103 on ClinicalTrials.gov