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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04807998

Enrollment

300

Registered

2021-03-19

Start date

2020-09-28

Completion date

2021-12-31

Last updated

2021-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Agitation, Metabolomics, Pain

Keywords

pediatric emergence agitation, postoperative Pain, metabolomics

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
Risk factors for pain and emergence agitation following maxillofacial surgery in children	within 48 hours	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.
The levels of serum and urine metabolites in EA	within 24 hours	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.

Countries

China

Outcome results