Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT06671002
Eligibility Criteria:
Inclusion Criteria:
* No significant analgesic medication use before surgery as defined in the protocol
* Undergo one the following: elective tonsil removal (with or without adenoid removal), gallbladder removal (laparoscopic), and knee scope (arthroscopy).
Exclusion Criteria:
* Anticipated other surgery within 12 months
* Anticipated life expectancy of \<12 months
* Those that have legal guardians (due to special permission to enroll in trials)
* Participants with complex chronic conditions per the Pediatric Medical Complexity Algorithm (e.g., trisomy 21)
* Patients with contraindications to non-steroidal anti-inflammatory drug (NSAID) drugs in the NSAID arm, opioid drugs in the opioid arm, or acetaminophen will be excluded.
* Liver disease
* Acute psychiatric instability (defined as current uncontrolled severe depression, severe post-traumatic stress disorder (PTSD), or suicidal ideation), substance use disorder not in remission or treatment, and history of diversion of controlled substances (opioids)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
20 Years
Study:
NCT06671002
Study Brief:
Protocol Section:
NCT06671002