Perfusion Index in Assessment of Postoperative Pain in Children.

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245239
• Other study ID #: AIP0294591
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: April 2024

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Noha yahia Mohammed, MD
• Phone: 01001890194
• Email: noha.hgagy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• perfusion index
measurement of perfusion index

Locations

Country	Name	City	State
Egypt	Noha yahia Mohammed	Assiut	Assuit Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.