Machine Learning-Based Prediction of Postoperative Pain After Pediatric Ambulatory Surgery

NCT07274995 | Active Not Recruiting

• 1 other identifier: BS-ANES-GBA-01
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to predict pain after surgery in children of ages 1 to 3 years by using computer programming (machine learning). Participant children will be observed before, during, and after surgery. Before surgery, the investigators will record each child's age, sex, weight, and the parent's level of anxiety using a short questionnaire (STAI: State Trait Anxiety Inventory). During surgery, the investigators will note the type of the surgery, how long it takes, and the medication given for pain relief. After surgery, the child's pain will be checked using the FLACC (Face, Legs, Activity, Cry, Consolability) scale, which assesses the child's face, legs, activity, crying, and how easy they are to comfort. For each assesment the children will be given points from 0 to 2. Pain will be measured 2 times. Firstly when the child reaches to the postoperative recovery room after they are monitorized. Secondly after 30 minutes spending in recovery room. At both times the pain scores and vital signs (pulse pressure and saturation) will be noted. No additional medication or intervention will be done throughout the study. All information will be stored without names or personal details. A computer model will study 80% of the data and then test itself on the remaining 20% of the collected data to see how well it can predict pain.

Conditions

Pain, Acute Post-Operative; Ambulatory Surgical Procedures; Pediatric Pain; Pediatric Patient (1m-21y)

Keywords

postoperative pain; pain prediction; machine learning; artificial intelligence; pediatric surgery; ambulatory surgery; day-case surgery; analgesia; pain management; pediatric anesthesia

Outcome Measures

Primary Outcomes (1)

• Postoperative pain score (FLACC: Face, Legs, Activity, Cry, Consolability)

  Pain intensity will be assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability), the pain score is a validated behavioral assessment tool used to evaluate pain in pediatric patients who are unable to communicate verbally. The scale consists of five observational categories: facial expression, leg movement, activity level, crying, and consolability. Each category is scored from 0 to 2, resulting in a total score ranging from 0 to 10, with higher scores indicating greater pain intensity. Pain severity was classified as no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10).

  Upon arrival to the post-anesthesia recovery room and 30 minutes after recovery room admission of the patient.

Secondary Outcomes (4)

• Heart rate (beats per minute)

  Upon arrival to postoperative recovery room and 30 minutes after the recovery room admission.

• Oxygen saturation (SpO₂, %)

  Upon arrival to postoperative recovery room and 30 minutes after the recovery room admission.

• Change in pain score (ΔFLACC)

  Upon arrival to postoperative recovery room and 30 minutes after the recovery room admission

• Parental anxiety (STAI-State)

  Preoperative (≤60 minutes before induction of anesthesia/surgery)

Study Arms (1)

Pediatric Ambulatory Surgery (1-3 years)

Children aged 1-3 years scheduled for day-case surgery. Demographic, psychosocial, surgical, anesthetic, and perioperative physiological variables are recorded. Postoperative pain is assessed twice in the recovery unit using the FLACC scale. No additional interventions beyond standard care.

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 1 to 3 years scheduled for elective ambulatory surgical procedures under anesthesia at a single tertiary care center. Eligible participants will be consecutive patients meeting inclusion criteria, with parental informed consent obtained prior to enrollment.

You may qualify if:

• Children aged 1 to 3 years
• scheduled for ambulatory (day-case) surgical procedures under general anesthesia
• American Society of Anesthesiologists (ASA) Physical Status I-II
• informed consent obtained from parent/legal guardian

You may not qualify if:

• Known developmental delay or neurological disorder interfering with pain assessment
• Chronic analgesic or sedative medication use
• Emergency surgery cases
• Incomplete data or refusal of parental consent

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Başakşehir Çam ve Sakura Şehir Hastanesi

Istanbul, Başakşehir, 34480, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

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

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

TU (1)