Pediatric Pain Optimization After Tonsillectomy

Obstructive Sleep Apnea Clinical Trial

Official title:

Pediatric Pain Optimization After Tonsillectomy: A Randomized Double Blind Methadone Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05244226
• Other study ID #: Pro00109911
• Status: Completed
• Phase: Phase 2
• Start date: April 8, 2022
• Est. completion date: May 10, 2023

Study information

• Verified date: November 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following tonsillectomy surgery.

Description:

This is a single center, randomized, double blind, parallel-group dose escalation investigation which will compare post operative pain control indices for patients receiving short acting versus long acting opioids as intraoperative analgesics. Surgical and anesthesia care, except for intraoperative opioid management, are not altered for study purposes. Subjects are randomized 2:1 to either long-duration (methadone) or short-duration opioid (fentanyl, hydromorphone) through the perioperative period. Exploratory data will be collected for up to 30 days post-operatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 10, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

Inclusion Criteria:

• Children ages 3 to 17 years old
• Presenting for elective tonsillectomy +/- adenoidectomy
• Provide informed consent / assent (as appropriate)

Exclusion Criteria:

• History of liver or kidney disease
• Females with positive pregnancy test
• Severe sleep apnea (Sleep study with Apnea Hypopnea Index (AHI) > 10)
• Consistent daily opioid use for chronic pain ( >3 months)

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Pain, Procedural
• Sleep Apnea, Obstructive
• Tonsillitis

Intervention

Drug:
• Fentanyl/Hydromorphone
Per routine care
• Methadone
Initial dosing 0.1mg/kg, potential to escalate to 0.15mg/kg following interim analysis

Locations

Country	Name	City	State
United States	Duke University School of Medicine	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of opioid medications administered	Postoperative opioid medication expressed in morphine equivalents per kilogram	Up to 7 days post surgery
Secondary	Evaluation of participant's pain as measured by Parent Post operative Pain Measure (PPPM)	Parent Post operative Pain Measure (PPPM) 15 yes/no questions which results in a score from 0-15. A score of at least 6 out of 15 signifies clinically significant pain.	Up to 7 days post surgery
Secondary	NIH PROMIS Parent Proxy Report Scale	Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always	Up to 7 days post surgery
Secondary	Evaluation of participant's pain as measured by Numeric Pain Rating Scale	Numeric Pain Rating Scale, 0-10. 0 no pain, 10 worst possible pain	Up to 7 days post surgery
Secondary	Prescription opioid use following hospital discharge	Number of doses of prescription medication used, 0 doses-all doses in prescription	Up to 7 days post surgery
Secondary	Opioid administration in the PACU (post-anesthesia care unit)	Opioid medication use in the recovery room expressed in morphine equivalents per kilogram	Up to 6 hours post surgery