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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04807998
• Other study ID #: SH9H-2020-T149
• Status: Active, not recruiting
• Start date: September 28, 2020
• Est. completion date: December 2021

Study information

• Verified date: November 2021
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergence Agitation
• Emergence Delirium
• Metabolomics
• Pain
• Psychomotor Agitation

Locations

Country	Name	City	State
China	Shanghai No.9 People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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