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Completed

NCT Number: NCT05244226

Pediatric Pain Optimization After Tonsillectomy

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Infections Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stomatognathic Diseases Tonsillitis

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke University School of Medicine

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fentanyl/Hydromorphone

Drug

Per routine care

Methadone

Drug

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

Primary outcomes

  1. Total Amount of Opioid Medications Administered

    Time frame: Up to 7 days post surgery

    Postoperative opioid medication expressed in oral morphine equivalents (OME) per kilogram

Secondary outcomes

  1. Percentage of Scores on the Parent Post Operative Pain Measure (PPPM) That Indicate Clinically Significant Pain

    Time frame: Up to 7 days post surgery

    The PPPM has 15 yes/no questions which results in a score from 0-15, where a higher score indicates greater pain. A score of at least 6 out of 15 signifies clinically significant pain. The percentage of scores > or = 6 is shown below.

  2. NIH PROMIS (Patient-Reported Outcomes Measurement Information System) Parent Proxy Report Scale

    Time frame: Up to 7 days post surgery

    Patient caregiver (as proxy) pain scores over past 7 days. Scale of 1 to 6, where 1=had no pain and 6=almost always had pain.

  3. Evaluation of Participant's Pain as Measured by Numeric Pain Rating Scale

    Time frame: Up to 7 days post surgery

    Numeric Pain Rating Scale has a range of 0 to 10, where 0=no pain and 10=worst possible pain.

  4. Doses of Prescription Opioid Used Following Hospital Discharge

    Time frame: Up to 7 days post surgery

    Number of doses of prescription medication used.

  5. Opioid Administration in the PACU (Post-anesthesia Care Unit)

    Time frame: Up to 6 hours post surgery

    Opioid medication use in the recovery room expressed in oral morphine equivalents (OME) per kilogram.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2022
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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