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Perfusion Index in Assessment of Postoperative Pain in Children.

A

Assiut University

Status

Enrolling

Conditions

Postoperative Pain

Treatments

Device: perfusion index

Study type

Observational

Funder types

Other

Identifiers

NCT06245239
AIP0294591

Details and patient eligibility

About

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.

Full 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

Enrollment

65 estimated patients

Sex

All

Ages

1 day to 3 years old

Volunteers

No Healthy Volunteers

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.

Trial design

65 participants in 1 patient group

group I
Description:
children aged \< 3years undergoing hypospadias repair surgery.
Treatment:
Device: perfusion index

Trial contacts and locations

1

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Central trial contact

Zeinab Mustafa Sayed, MD; Noha yahia Mohammed, MD

Data sourced from clinicaltrials.gov

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