Postoperative Chronic Pain in Children Aged 8 to 17

NCT ID: NCT07120399

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

323 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-15

Study Completion Date

2026-08-15

Brief Summary

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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

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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.

Conditions

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Postoperative Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Onur ERDEM

Research Assistant Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kocaeli University Faculty of Medicine

Kocaeli, Izmit, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Onur ERDEM, Medical Doctor

Role: CONTACT

+905526904115

Can AKSU, Associate Professor

Role: CONTACT

+905332568290

Facility Contacts

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Onur ERDEM, Medical Doctor

Role: primary

+905526904115

Other Identifiers

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GOKAEK-2025/06/39

Identifier Type: -

Identifier Source: org_study_id

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