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Postoperative Chronic Pain in Children Aged 8 to 17

K

Kocaeli University

Status

Not yet enrolling

Conditions

Postoperative Chronic Pain

Study type

Observational

Funder types

Other

Identifiers

NCT07120399
GOKAEK-2025/06/39

Details and patient eligibility

About

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.

Full 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.

Enrollment

323 estimated patients

Sex

All

Ages

8 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

323 participants in 1 patient group

Postoperative pediatric patients aged 8-17
Description:
Children aged 8 to 17 years who have undergone surgery and voluntarily agree to participate in the study for a period of six months will be included. To evaluate pain intensity, the Numeric Rating Scale (NRS) will be utilized, while the Pediatric Quality of Life Inventory 4.0 (PedsQL) will be used to assess quality of life. The assessment parameters will be administered at multiple time points: in the preoperative period, at discharge, and on postoperative day 7, as well as at 1 month, 3 months, and 6 months following surgery.

Trial contacts and locations

1

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Central trial contact

Onur ERDEM, Medical Doctor; Can AKSU, Associate Professor

Data sourced from clinicaltrials.gov

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