Status:
RECRUITING
Latinx Children and Surgery
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Pain, Postoperative
Pain, Acute
Eligibility:
All Genders
2-7 years
Phase:
NA
Brief Summary
Over 60 million persons in the United States (US) identify themselves as Latinx and 25.6% are children under the age of 16. Surgical disparities for adults and children have been identified as a majo...
Eligibility Criteria
Inclusion
- Children:
- Children age 2-7 who are scheduled to undergo outpatient surgery.
- Children of Latinx parents, who speak Spanish as a primary language and who may speak English
- Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study. ASA status I refers to "patients who are normal and healthy with no known systemic disease". ASA status II refers to "patients who have mild or well-controlled systemic diseases," such as non-insulin dependent diabetes, upper respiratory conditions, well-controlled asthma or allergies. ASA status III refers to patients who have moderate or severe systemic disease, which does limit their activities (e.g., stable angina or diabetes with systemic sequellae). This criteria was chosen as this group of children will typically undergo surgery in an outpatient setting. ASA status IV children will most likely undergo surgery in an inpatient setting and represents a much sicker population of children with different barriers.
- Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents at the time of recruitment. The rationale for excluding patients with developmental delay is that it is unknown whether parents manage their children's postoperative pain differently than in the general population. To generalize the findings to the general population, children with developmental delays will be excluded.
Exclusion
- Children with health status defined by ASA status IV-V will be excluded from this study. ASA status IV refers to "patients with an incapacitating systemic disease that is a constant threat to life". ASA status V "patients are considered moribund".
- Children whose parents do not identify as Latinx will be excluded from this study.
- Children who are taking psychotropic or pain medications that affect emotion modulation will be excluded from this study because of the potential for confounding effects on pain.
- Children with current malignant or any other disease or pain condition will be excluded as this may impact postoperative pain and thus be a confounding variable.
- Parent:
- Inclusion Criteria:
- 1\. Latinx Parents of children who are enrolled in the study who speak Spanish as a primary language and who may speak English.
Key Trial Info
Start Date :
August 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06020677
Start Date
August 23 2023
End Date
August 31 2027
Last Update
March 3 2025
Active Locations (1)
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1
Children's Hospital of Orange County
Orange, California, United States, 92868