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Pediatric Pain Optimization After Tonsillectomy

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05244226
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
22.8
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Pediatric Pain Optimization After Tonsillectomy: A Randomized Double Blind Methadone Pilot Study
Actual Study Start Date :
Apr 8, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Short acting opioids: Fentanyl, Hydromorphone

Drug: Fentanyl/Hydromorphone
Per routine care
Active Comparator: Long Acting Opioid: Methadone

Drug: Methadone
Initial dosing 0.1mg/kg, potential to escalate to 0.15mg/kg following interim analysis

Outcome Measures

Primary Outcome Measures

  1. Total amount of opioid medications administered - short acting opioid group [Up to 7 days post surgery]

    Postoperative opioid medication expressed in morphine equivalents per kilogram

  2. Total amount of opioid medications administered - long acting opioid group [Up to 7 days post surgery]

    Postoperative opioid medication expressed in morphine equivalents per kilogram

Secondary Outcome Measures

  1. Evaluation of participant's pain - short acting opioid group [Up to 7 days post surgery]

    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.

  2. Evaluation of participant's pain - long acting opioid group [Up to 7 days post surgery]

    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.

  3. NIH PROMIS Parent Proxy Report Scale - short acting opioid group [Up to 7 days post surgery]

    Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always

  4. NIH PROMIS Parent Proxy Report Scale - long acting opioid group [Up to 7 days post surgery]

    Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always

  5. Evaluation of participant's pain - short acting opioid group [Up to 7 days post surgery]

    Numeric Pain Rating Scale, 0-10. 0 no pain, 10 worst possible pain

  6. Evaluation of participant's pain - long acting opioid group [Up to 7 days post surgery]

    Numeric Pain Rating Scale, 0-10. 0 no pain, 10 worst possible pain

  7. Prescription opioid use following hospital discharge - short acting opioid group [Up to 7 days post surgery]

    Number of doses of prescription medication used, 0 doses-all doses in prescription

  8. Prescription opioid use following hospital discharge - long acting opioid group [Up to 7 days post surgery]

    Number of doses of prescription medication used, 0 doses-all doses in prescription

  9. Opioid administration in the PACU - short acting opioid group [Up to 6 hours post surgery]

    Opioid medication use in the recovery room expressed in morphine equivalents per kilogram

  10. Opioid administration in the PACU - long acting opioid group [Up to 6 hours post surgery]

    Opioid medication use in the recovery room expressed in morphine equivalents per kilogram

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Children ages 3 to 17 years old years

  2. Presenting for elective tonsillectomy +/- adenoidectomy

  3. Provide informed consent / assent (as appropriate)

Exclusion Criteria:

  1. History of liver or kidney disease

  2. Females with positive pregnancy test

  3. Severe sleep apnea (Sleep study with Apnea Hypopnea Index (AHI) > 10)

  4. Consistent daily opioid use for chronic pain ( >3 months)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University School of Medicine Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Lisa M Einhorn, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05244226
Other Study ID Numbers:
  • Pro00109911
First Posted:
Feb 17, 2022
Last Update Posted:
Apr 14, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Tonsillitis
Sleep Apnea, Obstructive
Pain, Procedural
Fentanyl
Methadone
Hydromorphone

Study Results

No Results Posted as of Apr 14, 2022