Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
210 participants
OBSERVATIONAL
2023-09-01
2029-07-01
Brief Summary
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Aim 2: To determine whether the effects of testosterone on postoperative pain and opioid use are mediated by immune factors
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Detailed Description
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In addition, before or after the surgery, patients and their parents/guardians will be interviewed. The interview will include questions about the surgery and about potential future study assessing the efficacy of sex hormone treatment on opioid use.
Longitudinal measures. At routine follow-up with the surgeons or after 1 week, 1 month, 3 months, and 6 months, study staff will contact patients to inquire about persistent pain (location, severity), and persistent opioid use. Based on previous studies, we estimate that ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.After signing the consent and assent forms, participants and their parents/guardians will complete several surveys, including demographic, behavioral, pain, substance use and analgesic risk assessment measures, and developmental surveys. In addition, a blood sample (for hormonal and immune analyses) will be collected on the day of the surgery and/or postoperative. Surgery-related parameters including postoperative pain, and opioid type and doses during the hospital time will be collected.
In addition, before or after the surgery, patients and their parents/guardians will be interviewed. The interview will include questions about the surgery and about potential future study assessing the efficacy of sex hormone treatment on opioid use.
Longitudinal measures. At routine follow-up with the surgeons or after 1 week, 1 month, 3 months, and 6 months, study staff will contact patients to inquire about persistent pain (location, severity), and persistent opioid use. Based on previous studies, we estimate that ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Postoperative patients
Pediatric female patients undergoing a surgical procedure
Pain
Postoperative pain levels
Opioid use
Postoperative opioid use
Interventions
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Pain
Postoperative pain levels
Opioid use
Postoperative opioid use
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
11 Years
16 Years
FEMALE
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Hadas Nahman-Averbuch
Asst Prof of Anesthesiology
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Facility Contacts
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Other Identifiers
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202210083
Identifier Type: -
Identifier Source: org_study_id
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