Postoperative Chronic Pain in Children Aged 8 to 17

NCT07120399 | Not Yet Recruiting

• 1 other identifier: GOKAEK-2025/06/39
• Study Type: observational
• Target: 323
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Chronic Pain

Keywords

Pain; Postoperative Chronic Pain; Quality of Life

Outcome Measures

Primary Outcomes (1)

• The Numeric Rating Scale (NRS)

  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.

  Six months

Secondary Outcomes (1)

• The Pediatric Quality of Life Inventory (PedsQL)

  Six months

Study Arms (1)

Postoperative pediatric patients aged 8-17

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.

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients aged 8 to 17 years who underwent surgical procedures at Kocaeli University

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University Faculty of Medicine

Kocaeli, Izmit, 41100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Onur ERDEM, Medical Doctor

CONTACT

+905526904115; mdonurerdem@gmail.com

Can AKSU, Associate Professor

CONTACT

+905332568290; dr.aksu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Doctor

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: August 15, 2025
• Primary Completion: February 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)