Perfusion Index as an Objective Measure for Postoperative Pain Assessment in Pediatric Patients.

August 30, 2020 updated by: Abeer Ahmed, MD, Cairo University

Evaluation of Perfusion Index as an Objective Measure for Postoperative Pain Assessment in Pediatric Patients Undergoing Adenotonsillectomy. An Observational Study.

It has been demonstrated that infants and children experience pain in a similar manner to adults, however it used to be undertreated when compared to adult.

Perfusion Index (PI) derived from pulse plethysmography waveform, represents a ratio of pulsatile signal (during arterial inflow) to non-pulsatile signal. PI can represent the peripheral perfusion dynamics due to change of peripheral vasomotor tone. Low PI values suggest peripheral vasoconstriction and high PI values suggest peripheral vasodilation.

The sympathetic nervous system is inherently involved in the pathophysiological responses evoked by painful stimulation.

In the current study, investigators hypothesise that the PI could be a good objective tool for assessment of postoperative pain in children undergoing adenotonsillectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

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

  • Egypt
      • Cairo, Egypt, 002211
        • Abeer Ahmed
      • Cairo, Egypt, 00225
        • Kasr Alainy Faculty of Medicine - Cairo university
      • Cairo, Egypt
        • Anesthesia department - Faculty of medicine- Cairo University

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

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children 3-7 years, ASA physical status I or II, undergoing Adenotonsillectomy will be included

Description

Inclusion Criteria:

  1. ASA physical status I-II
  2. Age 3 to 7 years
  3. Children undergoing adenotonsillectomy.

Exclusion Criteria:

  1. Parents' refusal.
  2. Children with behavioral changes
  3. Children with physical developmental delay
  4. Children on treatment with sedative or anticonvulsant.

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: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between postoperative (Children's Hospital of Eastern Ontario Scale ) CHEOPS score and postoperative perfusion index.
Time Frame: the time span between arrival to PACU and for at least two hours postoperative
the time span between arrival to PACU and for at least two hours postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
validity of perfusion index to predict postoperative pain and the need of rescue analgesia
Time Frame: he time span between arrival to PACU and for at least two hours postoperative
he time span between arrival to PACU and for at least two hours postoperative

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 20, 2019

Primary Completion (Actual)

June 20, 2019

Study Completion (Actual)

September 20, 2019

Study Registration Dates

First Submitted

February 16, 2019

First Submitted That Met QC Criteria

February 23, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 30, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-110-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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