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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Pain, Emergence Agitation, Metabolomics

Participation Criteria
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Eligibility Criteria
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Eligibility Criteria in Part I Inclusion Criteria: Patients undergoing palatopharyngoplasty/tonsillar and/or adenoidectomy, auricle reconstruction, and photodynamic therapy for vascular malformations on face. Aged between 3 years and 12 years. American Society of Anesthesiologists(ASA) class I-II. Exclusion Criteria: Patients with developmental delays. Patients with mental disorders. Patients with severe liver and kidney damage,or other heart and lung disease. Reject to participate in the trials. Eligibility Criteria in Part II Inclusion Criteria: Patients who underwent adenoidectomy or adenotonsillectomy in part I of this study. Aged between 3 years and 7 years. American Society of Anesthesiologists(ASA) class I-II. Patients who underwent sevoflurane anesthesia maintainance. Exclusion Criteria: Patients with developmental delays or mental disorders. Patients with neurological or psychiatric diseases. Patients with severe liver and kidney damage,or other heart and lung disease. Patients with metabolic diseases or family inherited diseases. Patients who received drug treatment or intravenous nutritional supports.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group EA<br>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<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative Pain, metabolomics, pediatric emergence agitation