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NCT Number: NCT06245239

Perfusion Index in Assessment of Postoperative Pain in Children.

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.

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Key information

Age range

1 day–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Noha yahia Mohammed

Asyut, Assuit Governorate, 71515, Egypt

Location status: Recruiting

Location contact

Noha yahia Mohammed, MD

CONTACT

[email protected]

01001890194

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

perfusion index

Device

measurement of perfusion index

Other names: PI

Primary outcomes

  1. Detection of the validity of Perfusion index in predicting Postoperative pain assessed by FLACC score

    Time frame: 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.

    The FLACC score along with the corresponding Perfusion index readings

Study contacts

Contact information is provided by the study sponsor or research team.

Noha yahia Mohammed, MD

CONTACT

[email protected]

01001890194

Zeinab Mustafa Sayed, MD

CONTACT

[email protected]

01009071365

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 7, 2024
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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