Postoperative Chronic Pain in Children Aged 8 to 17

Not yet recruiting

• Conditions: Postoperative Chronic Pain

• Registration Number: NCT07120399
• Lead Sponsor: Kocaeli University

Brief Summary

The objective of this study is to assess the incidence of chronic postoperative pain in pediatric patients aged 8 to 17 years following surgical procedures. Furthermore, it seeks to identify potential risk factors contributing to the development of such pain and to evaluate its long-term implications.

Detailed Description

Children aged 8 to 17 years who have undergone surgery at Kocaeli University Faculty of Medicine and voluntarily agree to participate in the study for a duration of six months will be included.

Children with speech or communication disorders, those who experience postoperative complications, those with psychiatric or neurological conditions, or those with a history of chronic or long-term pain will be excluded from the study.

The participants and their families will be informed about the purpose of the study, the procedures to be followed, the duration of the study, and any potential risks. Written informed consent will be obtained from the parents of all participants. In addition, participants will be asked to complete the informed consent form.

Each participant will be asked to allocate approximately 15 minutes to complete the questionnaires and assessment tools used in the study.

Data such as age, gender, weight, height, ASA score, medical and surgical history, type of surgery, incision size, surgical site, duration of surgery, type of anesthesia and analgesia used, medication doses, intraoperative anesthesia records, length of hospital stay, and any surgical complications will be recorded.

To assess pain intensity, the Numeric Rating Scale (NRS) will be used, and to evaluate quality of life, the Pediatric Quality of Life Inventory 4.0 (PedsQL), which has a validated Turkish version, will be utilized.

These assessment tools will be administered at the following time points: preoperative period, at discharge, and on postoperative day 7, as well as at 1 month, 3 months, and 6 months after surgery.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-14
• Study Start: 2025-08-15
• Primary Completion: 2026-02-15
• Study Completion: 2026-08-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 323

Inclusion Criteria

• Voluntary participation
• Undergoing a surgical procedure under anesthesia at our hospital
• Availability of complete patient data for a 6-month postoperative follow-up period

Exclusion Criteria

• Presence of speech or communication disorders
• Development of postoperative complications
• Undergoing any additional surgical procedure for any reason during the 6 months follow-up period
• Having diagnosed psychiatric or neurological disorders
• Having a pre-existing history of chronic or long-term pain

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Numeric Rating Scale (NRS)	Six months	The Numeric Rating Scale (NRS) is a commonly used pain assessment tool that consists of a numerical scale ranging from 0 to 10. On this scale, 0 indicates no pain, 1 to 3 represents mild pain, 4 to 6 indicates moderate pain, 7 to 9 reflects severe pain, and 10 corresponds to unbearable pain. Patients are asked to select the number that best describes the intensity of pain they are experiencing.

Secondary Outcome Measures

Name	Time	Method
The Pediatric Quality of Life Inventory (PedsQL)	Six months	The Pediatric Quality of Life Inventory (PedsQL) is a tool designed to measure the quality of life in children and adolescents by assessing their physical, emotional, social, and school functioning. It can be used in both healthy individuals and children with chronic health conditions.; The PedsQL 4.0 consists of a total of 23 items grouped into four subscales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). The inventory includes two parallel forms: one for the child and one for the parent.; The items are rated using a 5-point Likert scale, where: 0 = Never a problem; 1. = Almost never a problem; 2. = Sometimes a problem; 3. = Often a problem; 4. = Almost always a problem; Scores are transformed so that higher scores indicate better quality of life. Score ranges are interpreted as follows: 80-100: Very good quality of life 60-79: Moderate quality of life 40-59: Low quality of life 0-39: Very low quality

Trial Locations

Locations (1)

Kocaeli University Faculty of Medicine; 🇹🇷 Kocaeli, Izmit, Turkey