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NCT Number: NCT07120399

Postoperative Chronic Pain in Children Aged 8 to 17

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.

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Key information

Conditions

Postoperative Chronic Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli University Faculty of Medicine

Kocaeli, Izmit, 41100, Turkey (Türkiye)

Location contact

Onur ERDEM, Medical Doctor

CONTACT

[email protected]

+905526904115

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The Numeric Rating Scale (NRS)

    Time frame: 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 outcomes

  1. The Pediatric Quality of Life Inventory (PedsQL)

    Time frame: 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

    • = Almost never a problem
    • = Sometimes a problem
    • = Often a problem
    • = 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

Study contacts

Contact information is provided by the study sponsor or research team.

Can AKSU, Associate Professor

CONTACT

[email protected]

+905332568290

Onur ERDEM, Medical Doctor

CONTACT

[email protected]

+905526904115

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Investigation of the Incidence of Postoperative Chronic Pain in Children Aged 8 to 17 Years

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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