Perfusion Index in Assessment of Postoperative Pain in Children.

Using Perfusion Index in Assessment of Postoperative Pain in Children Undergoing Hypospadias Repair Surgery: an Observational Follow up Study.

The aim of this study will be to examine the validity of perfusion index in predicting pain and evaluation of its severity in the postoperative period.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Device: perfusion index

Detailed Description

* Hypospadias repair is a common surgery that is accompanied with significant postoperative pain. The largest group of children usually undergo this type of surgery are infants and pre-verbal children who cannot verbally report pain, and their treatment depends typically on behavioral and observational tools. Although these tools are valid and reliable measures in assessment of pediatric pain, they are still hindered by their subjectivity, which consequently could result in inadequate pain treatment that in early childhood may lead to negative behavioral and neurophysiological sequalae.

That is why recent studies have focused on developing more objective measures to evaluate pain especially when self-report is not possible.

* Changes in perfusion index(PI) caused by sympathetic stimulation refers to possible correlation between pain and PI which forms the basis of our study proposing that the PI is a non-invasive easy method that can be used in evaluating pain in infants

• Study Type: Observational
• Enrollment (Estimated): 65

Contacts and Locations

• Study Contact: Name: Noha yahia Mohammed, MD; Phone Number: 01001890194; Email: noha.hgagy@gmail.com
• Study Contact Backup: Name: Zeinab Mustafa Sayed, MD; Phone Number: 01009071365; Email: zeinab.mostafa.89@gmail.com

Study Locations

• Egypt
  • Assuit Governorate
    • Assiut, Assuit Governorate, Egypt, 71515
      • Recruiting
      • Noha yahia Mohammed
      • Contact: Noha yahia Mohammed, MD; Phone Number: 01001890194; Email: noha.hgagy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children aged<3 years of both sexes undergoing hypospadias repair surgery.

Description

Inclusion Criteria:

1. patients aged <3 years
2. Sex:- both male and female.
3. ASA I-II
4. Informed written consent obtained from parents or guardians of all patients.
5. Undergoing hypospadias repair surgery

Exclusion Criteria:

1. Patients outside the selective age range
2. Parents or guardians refusing to enroll their child in the study.
3. ASA III or VI
4. Children with behavioral changes or physical developmental delay
5. Children treated with sedatives or anticonvulsants.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group I; children aged < 3years undergoing hypospadias repair surgery.	Device: perfusion index; measurement of perfusion index; Other Names: PI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of the validity of Perfusion index in predicting Postoperative pain assessed by FLACC score	The FLACC score along with the corresponding Perfusion index readings	The baseline preoperative Perfusion index., The FLACC score along with the corresponding Perfusion index readings, will be recorded postoperatively: upon arrival to the PACU and every 30 minutes for 2 hours, then at 6, 12, 18, 24 hours.

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Noha yahia Mohammed, MD, lecturer of anesthesia, faculty of medicine, Assiut university, Egypt

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: February 3, 2024
• First Posted (Estimated): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: AIP0294591

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No