Risk Factors for Pediatric Emergence Agitation and Analysis of Serum or Urine Metabonomics in Children With Agitation

Risk Factors for Pediatric Emergence Agitation and Post-operative Pain Following Maxillofacial Surgery and Analysis of Serum or Urine Metabonomics in Children With Agitation-An Exploratory Study

It is known that some factors are associated with emergence agitation(EA), and investigators are still unable to predict accurately those who undergoing maxillofacial surgery are at great risks.This study intend to identify the risk factors for EA and to explore the mechanism of EA , which is helpful for early prediction, prevention and treatment in children.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain; Emergence Agitation; Metabolomics

Detailed Description

This study was divided into two parts. The first part, multivariate regression analysis were conducted to identify the risk factors for pain and EA following maxillofacial surgery in children. The second part, metabolomics research was used to explore the relationship between metabolites and EA in children.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai No.9 People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing palatopharyngoplasty/tonsillar and/or adenoidectomy, auricle reconstruction, and photodynamic therapy for vascular malformations on face.

Description

Eligibility Criteria in Part I

Inclusion Criteria:

1. Patients undergoing palatopharyngoplasty/tonsillar and/or adenoidectomy, auricle reconstruction, and photodynamic therapy for vascular malformations on face.
2. Aged between 3 years and 12 years.
3. American Society of Anesthesiologists(ASA) class I-II.

Exclusion Criteria:

1. Patients with developmental delays.
2. Patients with mental disorders.
3. Patients with severe liver and kidney damage,or other heart and lung disease.
4. Reject to participate in the trials.

Eligibility Criteria in Part II

Inclusion Criteria:

1. Patients who underwent adenoidectomy or adenotonsillectomy in part I of this study.
2. Aged between 3 years and 7 years.
3. American Society of Anesthesiologists(ASA) class I-II.
4. Patients who underwent sevoflurane anesthesia maintainance.

Exclusion Criteria:

1. Patients with developmental delays or mental disorders.
2. Patients with neurological or psychiatric diseases.
3. Patients with severe liver and kidney damage,or other heart and lung disease.
4. Patients with metabolic diseases or family inherited diseases.
5. Patients who received drug treatment or intravenous nutritional supports.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group EA; Serum and Urine samples were collected before anesthesia and immediately after surgery from children who enrolled in part I and undergoing the adenoidectomy or adenotonsillectomy. A PAED score of 12 or greater was defined as EA. The serum and urine samples were analyzed by UHPLC-Q-TOF/MS separately.
Group non-EA; Serum and Urine samples were collected before anesthesia and immediately after surgery from children who enrolled in part I and undergoing the adenoidectomy or adenotonsillectomy. A PAED score less than 12 was defined as non-EA. The serum and urine samples were analyzed by UHPLC-Q-TOF/MS separately.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for pain and emergence agitation following maxillofacial surgery in children	Children aged 3-12 years who undergoing palatopharyngoplasty/adenoidectomy or adenotonsillectomy, auricle reconstruction, and photodynamic therapy for vascular malformations were enrolled in this study. The general information of children, preoperative anxiety state, preoperative anxiety state of parents, operation type, anesthesia method, analgesic drug, postoperative pain and emergence agitation degree were collected. Multivariate regression analysis were conducted to identify the risk factors for pain and emergence agitation following maxillofacial surgery in children.	within 48 hours
The levels of serum and urine metabolites in EA	Children who underwent adenoidectomy or adenotonsillectomy in part I of this study were included. Urine (5ml) and peripheral venous blood (1ml) samples were collected before anesthesia and immediately after completion of agitation score. EA was defined as a Pediatric anesthesia emergence delirium(PAED) score ≥12 points. Children in EA group were matched with non-EA group, and UPLC-Q TOF/MS analysis was performed to identify the metabolites between two groups during the recovery period.	within 24 hours

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Study Chair: Jingjie Li, M.D, Shanghai No.9 People's Hospital

Publications and helpful links

General Publications

• Li Y, Li J, Shi Y, Zhou X, Feng W, Han L, Ma D, Jiang H, Yuan Y. Urinary Aromatic Amino Acid Metabolites Associated With Postoperative Emergence Agitation in Paediatric Patients After General Anaesthesia: Urine Metabolomics Study. Front Pharmacol. 2022 Jul 19;13:932776. doi: 10.3389/fphar.2022.932776. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: metabolomics; pediatric emergence agitation; postoperative Pain
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Emergence Delirium
• Other Study ID Numbers: SH9H-2020-T149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No