Perfusion Index to Measure Postoperative Pain in Kids After Adenotonsillectomy
Official title: Evaluation of Postoperative Pain With Perfusion Index Measurement in Pediatric Adenotonsillectomy: A Randomized Controlled Trial
Run by Istanbul University · NCT07915804 · Data updated 2026-11-12
This study tests whether the perfusion index can reliably reflect pain levels in children aged 1–12 after adenotonsillectomy, comparing standard care with an added glossopharyngeal nerve block.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Year to 12 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Istanbul University Academic / other |
| Locations | 1 site (Istanbul, Istanbul) |
| Status | Recruiting |
| Started | October 5, 2026 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07915804 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pediatric patients aged 1–12 years scheduled for elective adenotonsillectomy, ASA I–II, with parental/guardian consent.
✕Probably not a fit
Patients with ASA III–IV, perioperative instability, known local anesthetic allergy, chronic pain or neurological disease, or other conditions affecting peripheral perfusion may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center randomized trial will enroll 50 pediatric patients aged 1–12 undergoing elective adenotonsillectomy. Participants will be randomized to receive either standard general anesthesia with multimodal analgesia or the same regimen plus a bilateral glossopharyngeal nerve block with 0.25% bupivacaine. Postoperative perfusion index measurements will be compared to established pain scales (FLACC and Wong-Baker) to determine if PI aligns with patient-reported pain indicators. A standardized perioperative protocol will be used for all participants, including antibiotic prophylaxis, steroids, acetaminophen, and temperature management. The study aims to determine if PI can serve as an objective pain measurement tool in this pediatric surgical population.
Why it matters
Potential benefit: If successful, PI could provide an objective, real-time measure of postoperative pain in children, potentially improving pain management.
How similar studies have gone: Previous work has explored perfusion-based measures and nerve blocks for pain, but using perfusion index as a primary objective pain metric in this setting is novel and not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric patients aged 1-12 years * Scheduled to undergo elective adenotonsillectomy * American Society of Anesthesiologists (ASA) physical status I-II * Written informed consent obtained from a parent or legal guardian Exclusion Criteria: * American Society of Anesthesiologists (ASA) physical status III or higher * Perioperative hemodynamic instability * Perioperative respiratory instability * Known allergy to local anesthetic agents * Chronic pain or neurological disease * Peripheral circulatory disorders that may affect perfusion index measurements * Anticipated need for postoperative intensive care * Absence of written informed consent from a parent or legal guardian
Where it's running
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Istanbul University, Istanbul Faculty of Medicine, Department of Anesthesiology and Reanimation
Istanbul, Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Salih A AKINCI, Research Assistant — Istanbul University
- Study coordinator: Salih A AKINCI, Research Assistant
- Email: salih.akinci@istanbul.edu.tr
- Phone: +905524338021
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.