Perfusion Index in Assessment of Postoperative Pain in Children.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-05-31

Brief Summary

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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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Detailed Description

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\* 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

Conditions

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Postoperative Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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group I

children aged \< 3years undergoing hypospadias repair surgery.

perfusion index

Intervention Type DEVICE

measurement of perfusion index

Interventions

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perfusion index

measurement of perfusion index

Intervention Type DEVICE

Other Intervention Names

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PI

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No