Effect of Preoperative Fasting Duration on Postoperative Pain and Emergence Agitation in Pediatric Patients Undergoing Urogenital Surgery

NCT07552259 | Not Yet Recruiting

• 1 other identifier: 2025/601
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of preoperative fasting duration on postoperative pain and emergence agitation in pediatric patients undergoing urogenital surgery.

Conditions

Emergence Delirium; Emergence Agitation; Postoperative Pain

Keywords

Preoperative Fasting; Pediatric Anesthesia; FLACC; PAED; Urogenital Surgery; Postoperative Pain; Postoperative Agitation

Outcome Measures

Primary Outcomes (1)

• Postoperative agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale in the post-anesthesia care unit

  Each item is scored from 0 to 4. Items 1-3 (Positive behaviors - reverse scored): The child makes eye contact with the caregiver The child's actions are purposeful The child is aware of his/her surroundings 4 = Not at all 3 = Just a little 2 = Quite a bit 1 = Very much 0 = Extremely Items 4-5 (Negative behaviors): The child is restless The child is inconsolable 0 = Not at all 1. = Just a little 2. = Quite a bit 3. = Very much 4. = Extremely Total Score Range: 0-20 Interpretation * 10 → Suggestive of emergence delirium * 12 → Strongly indicative / more severe delirium

  One day

Study Arms (1)

İn Children Aged 2-8 Years Undergoing Elective Urogenital Surgery:

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of pediatric patients aged 2-8 years with ASA physical status I-II undergoing elective urogenital surgery at a single tertiary care university hospital. Eligible participants will be consecutively recruited and assessed preoperatively together with their parents or legal guardians.

You may qualify if:

• Age between 2 and 8 years
• ASA physical status I-II
• Scheduled for elective urogenital surgery

You may not qualify if:

• ASA physical status ≥ III
• Malnutrition
• Neuropsychiatric disorders
• Respiratory tract infection
• Developmental delay
• Surgery longer than 2 hours

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Medicine

Kayseri, Turkey (Türkiye)

Location

Related Publications (4)

• Thomas M, Morrison C, Newton R, Schindler E. Consensus statement on clear fluids fasting for elective pediatric general anesthesia. Paediatr Anaesth. 2018 May;28(5):411-414. doi: 10.1111/pan.13370. Epub 2018 Apr 27.

  PMID: 29700894 BACKGROUND

• Dabke T, Scott TE, Taylor B. Impact of preoperative fasting duration on perioperative complications in elective paediatric procedures: a systematic review and meta-analysis. Br J Anaesth. 2026 Jan;136(1):158-166. doi: 10.1016/j.bja.2025.10.037. Epub 2025 Nov 27.

  PMID: 41314944 BACKGROUND

• Andersson H, Schmitz A, Frykholm P. Preoperative fasting guidelines in pediatric anesthesia: are we ready for a change? Curr Opin Anaesthesiol. 2018 Jun;31(3):342-348. doi: 10.1097/ACO.0000000000000582.

  PMID: 29443724 BACKGROUND

• Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.

  PMID: 28045707 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pain, Postoperative; Emergence Delirium

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

GAMZE TALIH, MD

CONTACT

+905447604780; gamzetalih@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)