Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

Launched by DUKE UNIVERSITY · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how to best manage pain in children and teenagers after they have their tonsils removed, a surgery known as tonsillectomy. The researchers want to compare two types of pain medications: short-acting opioids (like fentanyl and hydromorphone) and long-acting opioids (like methadone). They hope to find out which medication works better for controlling pain after surgery.

To be part of this study, children must be between 3 and 17 years old and scheduled for an elective tonsillectomy, with or without adenoid removal. Parents or guardians will need to provide consent, and children aged 7 and older will need to agree to participate as well. Participants can expect close monitoring during their recovery to see how well the pain medications work for them. It's important to note that children with certain health issues, such as chronic pain or severe sleep apnea, will not be eligible for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \>= 3 and \< 18 years
• • 2. Elective tonsillectomy +/- adenoidectomy
• • 3. Signed informed consent by parent or legal guardian
• • 4. Children \>= 12 years must provide signed written consent, Children \>= 7 years must provide verbal assent
• • 5. Negative pregnancy test within 48 hours for post pubescent females
• Exclusion Criteria:
• • 1. History of chronic kidney or liver disease
• • 2. Current diagnosis of a chronic pain disorder
• • 3. Planned admission to the Pediatric Intensive Care Unit (PICU)
• • 4. Additional procedures under general anesthesia for which opioids would be prescribed