OPTIMAL (Pediatric Tonsillectomy)

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.

Who Can Participate?

Eligibility

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.

Age Range

3-17

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital
Duke Regional Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

Single-Dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double Blind Clinical Trial

Principal Investigator

Lisa
Einhorn

Protocol Number

PRO00114677

NCT ID

NCT06576830

Phase

IV

Enrollment Status

Open to Enrollment
ClinicalTrials.gov