Institutional Review Board, Hospital for Special Surgery
August 24, 2017
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
We will enroll up to 80 patients until enrollment of 30 patients in each procedure group with the primary outcome is recorded. We expect patients in group 1 (knee arthroscopy, meniscal repair, and OCD lesion) to receive a prescription with 20 pills, and those in group 2 (ACL reconstruction, knee arthrotomy, and MPFL reconstruction) to receive a prescription with 40 pills. The primary outcome is the number of left over pills on POD14. Follow ups will occur on POD7 and POD14 and will take place over the phone or through an email survey.
- Patients age 12-19 years old
- Patients undergoing knee arthroscopy, OCD lesion/loose body, meniscal repair, ACL reconstruction, knee arthrotomy, or MPFL reconstruction with a pediatric surgeon.
- English speaking
- Patients younger than 12 years old or older than 19 years old
- Any opioid use in the past 6 months (as this population should not have received opioids for any reason pre-op)
- Any use of a controlled substance EXCEPT for the use of ADHD medication
- Inability to swallow medication in pill forms (patients requiring liquid prescriptions)
- Non-verbal or inability to consent to study
- Non-English speakers
Pamela K. Wendel, MD