Perfusion Index in Assessment of Postoperative Pain in Children.

NCT06245239 | Recruiting DMC

• 1 other identifier: AIP0294591
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

group I

children aged \< 3years undergoing hypospadias repair surgery.

Device: perfusion index

Interventions

perfusion index DEVICE

measurement of perfusion index

Also known as: PI

group I

Eligibility Criteria

• Age: 1 Day - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Noha yahia Mohammed

Asyut, Assuit Governorate, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Perfusion Index

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Noha yahia Mohammed, MD

  lecturer of anesthesia, faculty of medicine, Assiut university, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noha yahia Mohammed, MD

CONTACT

01001890194; noha.hgagy@gmail.com

Zeinab Mustafa Sayed, MD

CONTACT

01009071365; zeinab.mostafa.89@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and intensive care, faculty of medicine, Assiut University

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 7, 2024
• Study Start: June 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)