OPTIMAL (Pediatric Tonsillectomy) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out what pain management options work best for most children who have surgery to remove their tonsils (tonsillectomy). We will compare the outcomes of using fentanyl (a short-acting opioid) versus using methadone (a long-acting opioid) to control pain during and after surgery. Both drugs are commonly used for this purpose, but we don't have enough data to know which is the best option to reduce pain.
Tonsillectomy in Children
Who Can Participate in the Study?
Children ages 3-17 who:
- Are scheduled or plan to have a tonsillectomy at Duke University Hospital, Duke Regional Hospital, or a Duke-affiliated outpatient ambulatory surgical center (e.g., Davis Ambulatory Surgical Center)
- Do not have any type of pain disorder
- Will not need to use any opioid medication for pain management after surgery
For more information, contact the study team at nancy.hardesty@duke.edu.
What is Involved?
If you choose to have your child participate in this study, you will:
- Fill out a survey about your perception of opioids and surgery before your child's procedure
- Fill out daily surveys online about how your child is doing for each of the first 7 days following their surgery
- Fill out online surveys about how your child is doing 1 month, 3 months, and 6 months after your child's surgery
If your child is part of this study, they will get a random assignment (by chance) to get either fentanyl or methadone as part of their anesthesia during surgery. They will have a 2-in-3 chance of receiving methadone and a 1-in-3 chance of receiving fentanyl.
No child can be enrolled in this study without their parents' consent and participation. Children who are older than 7 must also agree and sign a consent form to take part in the study.
Study Details
