Trial Information

Summary: Chronic Pain Study

Who can participate?

Children ages 2 through 15 years of age who have been on pain medication for at least one week and will need to continue on them for at least 2.5 weeks will be included in this study.

What is involved?

This study lasts for two and one half weeks and includes approximately 6 visits. The following is a list of procedures that will take place during the study:

• Height, weight, and vital signs will be obtained
• A review of the patient’s medical history
• Respiratory rate and sedation levels will be measured
• Blood will be drawn 5 times during the study
• Pain levels will be recorded twice daily
• A parent/guardian and the child will complete a questionnaire at the beginning of the study

The direct benefit that your child may receive from participation in this study is that he or she may be relieved of his or her pain symptoms. If your child has difficulty taking oral medications the patch can allow your child to take medications without having to be confined to an IV. The patch is required to be changed every three days. Your child’s participation will also be of benefit to many other children. Clinical studies are essential in finding new and improved treatments and diagnostic tools. Your child may receive no direct benefit from participating in this study.

Will I get all the facts about the study?

Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. It goes over all of the procedures, the risks, the benefits, the compensation, who 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. Study procedures will not begin until a parent/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.

What are the risks?

The risks involved in this study include having a side effect from the medication and the risks of having blood drawn. The potential side effects are those similar to taking other pain medications such as nausea, constipation, and dry mouth. All of the risks will be thoroughly explained during the time of consent. Your child will be monitored closely throughout the entire study to minimize any potential risks. Study staff are available at all times to be contacted in case of an emergency.

What is the compensation?

Participants will be reimbursed for the time and travel involved in study visits.

For more information:

If you would like to learn more about participating in this study, please send an e-mail message using the form below.