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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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06245239
Enrollment
65
Registered
2024-02-07
Start date
2024-06-01
Completion date
2026-05-31
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

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

Interventions

DEVICEperfusion index

measurement of perfusion index

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 3 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Detection of the validity of Perfusion index in predicting Postoperative pain assessed by FLACC scoreThe 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

Countries

Egypt

Contacts

Primary ContactNoha yahia Mohammed, MD
noha.hgagy@gmail.com01001890194
Backup ContactZeinab Mustafa Sayed, MD
zeinab.mostafa.89@gmail.com01009071365

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026