Phoenixin and Pain in Pediatric Burn Patients

ConditionsChildren Acute Pain Burn Pain Burn Degree Second

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age1-18

SponsorAnkara City Hospital Bilkent

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population will consist of pediatric participants prospectively recruited at Ankara Bilkent City Hospital. The acute burn group will include children with acute second-degree burn injuries who are being followed and treated in the pediatric burn intensive care unit. The chronic burn group will consist of children with a previous burn injury, with at least three months elapsed since the burn, who are evaluated during follow-up after the acute phase. The healthy control group will consist of children without a history of burn injury who are evaluated at the same institution. Eligible participants will be consecutively enrolled from the relevant clinical units during the study period. The three groups will constitute the source population for the comparative evaluation of blood and urine phoenixin levels and their relationship with pain and burn-related clinical characteristics.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

87 Participants

are grouped into 3 trial groups

Group A: 1. Acute Burn Group

Group B: 2. Chronic Burn Group

Group C: 3. Healthy Control Group

Trial outcomes

Primary outcomes

Difference in Blood and Urine Phoenixin Levels Among the Study Groups

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.

Time frame