Using perfusion index to assess postoperative pain in children
Using Perfusion Index in Assessment of Postoperative Pain in Children Undergoing Hypospadias Repair Surgery: an Observational Follow up Study.
This study is testing if a special measurement called the perfusion index can help doctors understand and manage pain in young children after they have surgery for hypospadias.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 65 (estimated) |
| Ages | 1 Day to 3 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut, Assuit Governorate) |
| Trial ID | NCT06245239 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the validity of the perfusion index (PI) as a non-invasive method for predicting and assessing the severity of postoperative pain in infants and pre-verbal children undergoing hypospadias repair surgery. Given that these young patients cannot verbally communicate their pain, the study seeks to establish a correlation between changes in PI and pain levels, potentially leading to more objective pain management strategies. The research will involve monitoring the PI in children post-surgery to determine its effectiveness in pain evaluation.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged under 3 years who are undergoing hypospadias repair surgery.
Not a fit: Patients outside the age range of under 3 years or those with significant behavioral or developmental delays may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for infants and pre-verbal children after surgery.
How similar studies have performed: While the use of perfusion index in pain assessment is a relatively novel approach, recent studies have shown promise in developing objective measures for evaluating pain in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Asyut, Assuit Governorate
- Noha yahia Mohammed — Asyut, Assuit Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Noha yahia Mohammed, MD — lecturer of anesthesia, faculty of medicine, Assiut university, Egypt
- Study coordinator: Noha yahia Mohammed, MD
- Email: noha.hgagy@gmail.com
- Phone: 01001890194
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.