ERAS in Pediatric and Adolescent Gynecology: How Important is Preoperative Counseling in Patient Outcomes and Does Parent Versus Patient Counseling Impact Success?
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Enhanced Recovery After Surgery
- Sponsor
- University of Colorado, Denver
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Numeric Pain rating scores at post-op days 1 and 7
- Status
- Recruiting
- Last Updated
- 12 months ago
Overview
Brief Summary
The Investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for ERAS improves post-surgical pain scores. The Investigator will also assess participant compliance to ERAS-prescribed medications, and functionality (return to school). Each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling.
Detailed Description
Enhanced Recovery After Surgery (ERAS) protocols have been shown to be safe and effective in pediatric and adolescent gynecology (PAG) participants. However, the individual elements of ERAS that are associated with positive outcomes have not been identified. Pre-operative counseling and education is a standard component of ERAS. In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the participant's caregiver rather than directly to the participant. It is possible that direct participant involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes. To investigator's knowledge, no studies have examined the impact of direct participant involvement in pre-operative counseling on ERAS outcomes in the PAG population. The Investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for ERAS improves post-surgical pain scores. The Investigator will also assess participant compliance to ERAS-prescribed medications, and functionality (return to school). Each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling.
Investigators
Eligibility Criteria
Inclusion Criteria
- •9- 17 years of age
- •Patient is undergoing abdominal surgery and being managed under the ERAS protocol
Exclusion Criteria
- •Developmental delay (IQ \< 70) determined by documentation in medical record
- •Emergency or non-elective surgical cases
- •Patients who attend clinic appointments independently from their caregiver
Outcomes
Primary Outcomes
Numeric Pain rating scores at post-op days 1 and 7
Time Frame: 1-7 days after surgery
Minimum value = 0, maximum value = 10. 0 = no pain at all, 10 = worst pain imaginable. A higher score on the rating scale indicates a worse outcome.
Secondary Outcomes
- Rate of medication adherence to ERAS-prescribed medications(1-7 days after surgery)
- Number of participants who have returned to school at 7-days post-op(7 days after surgery)
- Rate of narcotic medication prescriptions(1-7 days after surgery)