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Starting soon Observational

Phoenixin and Pain in Pediatric Burn Patients

NCT07858409 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-10-01
Last updated
2026-10-05

Condition(s) studied

ChildrenAcute PainBurn PainBurn Degree Second

Study summary

This prospective, controlled, observational study aims to investigate the relationship between phoenixin (PNX) levels and pain in pediatric burn patients. A total of 87 prepubertal children under 18 years of age will be included and evaluated in three independent groups: 29 children with second-degree burns in the acute burn period and experiencing pain at the time of assessment, 29 children with a history of burn injury at least three months previously who have completed the acute burn and procedural pain period, and 29 age-similar healthy controls without a history of burns or acute pain.

Blood and urine samples will be collected from all participants, and PNX levels will be measured using an enzyme-linked immunosorbent assay (ELISA). Pain intensity will be assessed using age-appropriate validated pain assessment tools, including the Face, Legs, Activity, Cry, Consolability (FLACC) scale and the Visual Analog Scale (VAS), as appropriate. In the burn groups, burn characteristics, including total body surface area (TBSA), will also be recorded.

The study will compare blood and urine PNX levels among the acute burn, chronic burn, and healthy control groups and will evaluate the relationship between PNX levels and clinical pain intensity in children with acute burns. Secondary analyses will examine the relationships between blood and urine PNX levels and their associations with TBSA and demographic and clinical characteristics. The findings are expected to provide preliminary clinical data on the potential role of PNX as a pain-related biological marker in pediatric burn patients.

Eligibility

Sex
ALL
Min age
1 Month
Max age
18 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Inclusion Criteria: * Children younger than 18 years of age who have not entered puberty. * Both sexes are eligible. * Written informed consent for participation in the study obtained from a parent or legal guardian. * For the acute burn group: children with second-degree burns who are being followed in the burn intensive care unit. * For the chronic burn group: a history of burn injury, with at least three months elapsed since the burn. * For the control group: no history of burn injury and no acute pain at the time of assessment. Exclusion Criteria: * Neurological, endocrine, or active systemic inflammatory disease that may affect phoenixin (PNX) levels or pain assessment. * Having entered puberty. * Inability to obtain the biological samples required for the study. * Lack of written informed consent from a parent or legal guardian.

Primary outcome measure(s)

  • Difference in Blood and Urine Phoenixin Levels Among the Study Groups — At the time of study enrollment
    Blood and urine phoenixin (PNX) concentrations measured by enzyme-linked immunosorbent assay (ELISA) will be compared among the acute burn, chronic burn, and healthy control groups.
  • Association Between Phoenixin Levels and Pain Intensity in the Acute Burn Group — At the time of study enrollment
    The association between blood and urine PNX concentrations and clinical pain intensity will be evaluated in children with acute burns. Pain intensity will be assessed using an age-appropriate validated pain assessment scale (FLACC or VAS, as applicable).

Trial sites (1)

FacilityCityRegionStatus
Ankara City Hospital Bilkent Ankara Ankara
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07858409 on ClinicalTrials.gov ↗ ← All trials in Turkey