ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age9-17
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
9- 17 years of age
Patient is undergoing abdominal surgery and being managed under the ERAS protocol
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced Recovery After Surgery (ERAS) Counseling to Patients
Other interventionIn pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the patient's caregiver rather than directly to the patient. It is possible that direct patient involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes.
Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver
Other interventionIn pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the patient's caregiver rather than directly to the patient. It is possible that direct patient involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: pre-operative counseling with their caregiverActive comparator 1 intervention
Group B: caregiver-only counseling.Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Numeric Pain rating scores at post-op days 1 and 7
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.
Time frame
1-7 days after surgerySecondary outcomes
1
Number of participants who have returned to school at 7-days post-op
Yes/no question asking whether the participants has returned to school
Time frame
7 days after surgery2
Rate of medication adherence to ERAS-prescribed medications
Participants reported adherence to ERAS medications during the post-operative period measured by asking patients which medications they are taking.
Time frame
1-7 days after surgery3
Rate of narcotic medication prescriptions
Documentation of narcotic pain medications used during the post-operative period. Assessed via chart review of medical record.
Time frame
1-7 days after surgerySponsors and contacts
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Source ClinicalTrials.gov