Effect of Neutrophil Lymphocyte-platelet Lymphocyte Ratio on Complications in Pediatric Patients (NLOPEDI)

November 28, 2018 updated by: SİNAN YILMAZ, Aydin Adnan Menderes University

The Effect of Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio on Intraoperative and Postoperative Complications in Pediatric Patients Undergoing Otolaryngology

The aim of this study was to investigate the relationship between NLR, PLR and postoperative complications in children undergoing adenotonsillectomy and adenoidectomy.

Study Overview

Status

Completed

Detailed Description

Between the dates of February 1, 2018 and June 30, 2018, patients between 2-10 years of age, ASA I-II, elective adenotonsillectomy and adenoidectomy under general anesthesia were planned to be included in the study. The number of neutrophils, lymphocytes and platelets will be taken from the hospital registry system taken preoperatively and the NLR and PLR ratios will be calculated.

All patients in the operating room will be started with routine monitoring and anesthesia. Hemodynamic data during surgery will be recorded. The entrance to the operating room (T1), 5 minutes after the start of anesthesia (T5), 15 minutes (T15), 30 minutes (T30) and 45 minutes (T45) will be recorded in the follow-up form of the anesthesia. The fasting period of the patients and the drugs and fluids applied during surgery will be recorded from the anesthesia form. At the end of the operation, the patients who were taken to the recovery room at the end of the surgery will be evaluated with 1 point, 15 minutes, 30 minutes, 1 hour and 4 hours and 6 hours vomiting using the 4 point nausea scale.

Introduction to recovery room using Modified Eastern Ontario Children's Hospital Pain Scale (mCHEOPS), postoperative pain at 15 min, 30 min, 1 hr and 4 hr. Analgesic requirement will be recorded. Bronchospasm, agitation, etc. will be recorded by evaluating whether there are complications.

Study Type

Observational

Enrollment (Actual)

127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aydın, Turkey, 09100
        • Adnan Menderes University Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

2-10 years

Description

Inclusion Criteria:

  • Patients undergoing elective adenotonsillectomy and adenoidectomy under general anesthesia

Exclusion Criteria:

  • Immunodeficiency
  • Children of parents who do not want to participate in the study
  • Use of anticoagulants
  • Children with hematological disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
adenoidectomy group
Operations of adenoidectomy
adenotonsillectomy group
Operations of adenotonsillectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect on postoperative complications of neutrophil lymphocyte ratio in adenotonsillectomy and adenoidectomy PAIN
Time Frame: Postoperative 6 hours
Pain level will be evaluated by using CHEOPS (Children's Hospital of Eastern Ontario Pain Scale ) pain score. The scale includes six categories of pain behavior (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the total score ranges between 4 and 13.
Postoperative 6 hours
The effect on postoperative complications of neutrophil lymphocyte ratio in adenotonsillectomy and/or adenoidectomy POVN
Time Frame: Postoperative 6 hours
Pain level will be evaluated by using POVN score. Evaluation of nausea and vomiting was performed by a four-point scale; 0: No nausea and/or vomiting, 1: mild nausea and/or vomiting which does not require treatment, 2: nausea and/or vomiting requiring treatment and 3: vomiting resistant to antiemetic treatment
Postoperative 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

November 27, 2018

First Submitted That Met QC Criteria

November 27, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • NLOPEDİ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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