Do You or Your Child Have Idiopathic Scoliosis (Curved Spine) and/or Pectus Excavatum (Funnel Chest)? Are you Scheduled for a Surgical Clinic Visit?

What is the purpose of this study?

The goal of this research study is to improve the safety and effectiveness of opioid pain management. We plan to evaluate if putting a patient’s genetic test result into the medical record helps clinicians make decisions about opioid selection and dosing that leads to safe and effective pain management.

The genetic test analyzes a gene that is important for how a person responds to some opioids: codeine, hydrocodone, oxycodone or tramadol.

Who can participate?

Children, teens and adults, 6 to 21 years old, who have idiopathic scoliosis (curved spine) and/or pectus excavatum (sunken or funnel chest) and are scheduled for a surgical clinic visit.

What is involved?

You or your child will be in this study for up to 2 years and have up to 2 study visits.

The first visit includes the consent process. You or your child will receive an evaluation to determine whether or not you can participate in this study.

After you or your child qualify, and if you agree to participate, staff will collect demographic information (such as a date of birth, race, years of education) as well as a blood or saliva sample.

The second study visit occurs only if you or your child has surgery. As part of the second study visit we will collect information about how you are responding to pain medicines. A more detailed list of procedures will be provided to anyone interested in knowing more about this study.

What are the benefits?

You or your child will not receive a direct medical benefit from participating in this study. However, the information gained from this study may be beneficial in disease prevention, treatment or management.

Will I get all the facts about the study?

If you are interested in participating or having your child participate, you will be given a consent form that explains all of the details of the study.  The form covers all of the procedures, risks, benefits, pay, whom to contact with questions or concerns and more.  A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. 

What are the risks and discomforts of the study?

There are minimal risks associated with participating in this study. Any discomforts or risks will be discussed with you if you are interested in learning more about the study.

Do participants receive pay, compensation or reimbursement?

Participants may receive up to $30 for their time and travel.

Who should I contact for more information?

Matt Veerkamp

matthew.veerkamp@cchmc.org

513-803-3279

Center for Autoimmune Genomics and Etiology

Cincinnati Children’s Hospital Medical Center

3333 Burnet Avenue

Cincinnati, OH 45229-3039

Where can I find additional information?

Principal Investigator

Senthikumar Sadhasivam, MD, MPH

Principal Investigator

Department of Anesthesiology

Cincinnati Children’s Hospital Medical Center

Cynthia Prows, MSN, RN

Principal Investigator

Division of Human Genetics

Cincinnati Children's Hospital Medical Center

Co-Investigators:

Vidya Chidambaran, MD

David Moore, MD

Alexandra Szabova, MD

Smokey Clay, MD

Luigi Viola, MD