Pediatric Postoperative Pain Management

NCT07392827 | Completed

• 1 other identifier: SBA 25/704
• Study Type: observational
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, observational study evaluates the effectiveness of perioperative pain management strategies in pediatric patients undergoing elective surgical procedures. Pediatric patients aged 0-18 years were assessed using age-appropriate pain scales during the first postoperative hour to measure acute pain control. Pain scores, emergence delirium evaluations, and interventions administered during routine clinical care were recorded to determine the effectiveness of standard pain management approaches across age and surgical subgroups. This study will not interfere with the clinician's treatment methods in any way. The treatments applied and their frequency will be determined. The success of the procedures performed will also be evaluated.

Conditions

Pediatric Surgical Patients; Pediatric Anesthesia Department; Regional Anaesthesia; Pain Scale; Caudal Epidural Anesthesia; Postoperative Pain

Keywords

Pediatric postoperative pain management

Outcome Measures

Primary Outcomes (3)

• 0-59 months old age group pain intensity

  Postoperative pain intensity was assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale in pediatric patients aged 0-59 months. Pain scores ≥4 indicate moderate pain requiring intervention, whereas scores ≥7 indicate severe pain. Pain scores below 4 are defined as successful pain management. Score on FLACC scale (range 0-10)

  Within the first postoperative hour (0, 30, and 60 minutes after recovery).

• 60- 84 months old age group pain intensity

  Postoperative pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale in pediatric patients aged 60-84 months. Pain scores ≥4 indicate moderate pain requiring intervention, whereas scores ≥7 indicate severe pain. Pain scores below 4 are defined as successful pain management. Score on Wong-Baker FACES scale (range 0-10)

  Within the first postoperative hour (0, 30, and 60 minutes after recovery).

• 85 months -18 year of age group pain intensity

  Postoperative pain assessed using the VAS (Visual Analog Scale) in patients aged 85 months-18 years. Scores ≥4 indicate pain requiring intervention; scores ≥7 indicate severe pain. Scores \<4 indicate successful pain control. Unit of Measure: VAS score (0-10)

  Within the first postoperative hour (0, 30, and 60 minutes after recovery).

Secondary Outcomes (2)

• Need for rescue analgesia in the postoperative recovery unit

  Within the first postoperative hour (0, 30, and 60 minutes after recovery).

• Postoperative emergence delirium assessed by the PAED scale

  Within the first postoperative hour (0, 30, and 60 minutes after recovery).

Study Arms (1)

0-18 years old pediatric patiens

The main aim of this study is to evaluate all pediatric patients undergoing elective surgery; to accurately assess pain, the age groups were divided into 3. 0-59 months old patients will be evaluated with the FLACC scale, 60-84 months old patients' pain will be determined with the Wong-Baker FACES Scale, and 85 months-18 years old patients' pain will be assessed with the VAS score.

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Eligible pediatric patients undergoing elective surgery were consecutively enrolled during the study period.

You may qualify if:

• Patients aged 0-18 years operated on by the Pediatric Surgery Department,
• Elective pediatric operations are performed under general anesthesia,
• ASA I-III group patients,

You may not qualify if:

• o Hemodynamically unstable patients. o ASA IV-VI group patients with life-threatening conditions. o Patients requiring emergency surgery.
• Patients requiring emergency surgery. o Patients over 18 years of age,
• Patients admitted under sedation,
• Non-surgical diagnostic or minimally invasive procedures such as gastroscopy, colonoscopy, bronchoscopy, and direct laryngoscopy,
• Non-surgical needle biopsies,
• Catheter placement and removal procedures,
• Pain management interventions for chronic pain patients (TENS, Acupuncture),
• Neurological (patients with chronic analgesic syndrome, peripheral neuropathies, spinal cord injury, cerebral palsy, meningomyelocele, multiple sclerosis, and neurodegenerative diseases) and mental developmental delay (autism spectrum disorders, mental retardation, Down syndrome),
• Patients being followed up and treated for psychiatric illnesses (depression, anxiety disorder, somatization disorder, conversion disorder, schizophrenia, and bipolar disorder),
• Patients with chronic pain syndrome or neuropathic pain who are using continuous analgesics in the preoperative period. Patients with a history of drug and psychoactive substance use, patients who are intubated postoperatively or monitored under intensive sedation for a long period, patients who are hemodynamically unstable in the postoperative period, patients who develop serious postoperative complications (hemorrhage, sepsis, MOOS), patients who require repeat surgery during the postoperative follow-up period, patients for whom Informed Consent could not be obtained will be excluded from the study.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Hospital

Ankara, Altındag, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Filiz Uzumcugil, Professor Doctor

  Hacettepe University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 6, 2026
• Study Start: September 24, 2025
• Primary Completion: January 10, 2026
• Study Completion: February 10, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

TU (1)