A Phase 4 interventional study of Methadone and Fentanyl/Hydromorphone in Pain, Postoperative, Tonsillar Hypertrophy and Tonsillitis, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 3 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Duke University · Phase 4, Interventional, and Treatment
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 in children and adolescents.
This is a randomized, double-blind, parallel-group, dose-escalation investigation. Participants ("children" defined as ages 3 - \< 12 years and "adolescents" defined as ages 12 - 17 years) will be randomized 2:1 to either methadone or short-acting opioid. Surgical and anesthesia care, except for intraoperative opioid management, are not altered for study purposes. The trial will include 2 periods in 3 parallel age groups. In the first period, each age cohort will recruit 66 patients (44 methadone, 22 control). Children will be randomized to methadone 0.15 mg/kg age-ideal body weight and adolescents to 0.2 mg/kg age-ideal body weight. When an age cohort reaches 66 patients, this is the end of the first period. At that time, an unblinded interim analysis will be conducted in that cohort to determine if dose escalation to 0.2 mg/kg dose in children and the 0.25 mg/kg dose in adolescents are met. Methadone dose escalation will be based on clinically meaningful differences in need for rescue opioid in the PACU and the absence of well-defined opioid adverse events. Outcomes data will be collected in hospital and after discharge. With daily surveys for 7 days, and 3 phone calls on day 30, 3 months and 6 months after surgery.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 440 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Per Routine Care
Drug: Fentanyl/Hydromorphone
Initial Dosing: 0.15 mg/kg age-ideal body weight in children age 3 - \< 12 years and 0.2 mg/kg age-ideal body weight in adolescents age 12 - 17 years. Dose escalation (possible, based on interim analysis): 0.2 mg/kg age-ideal body weight in children age 3 - \< 12 years and 0.25 mg/kg age-ideal body weight in adolescents age 12 - 17 years.
Drug: Methadone
Single-dose intraoperative intravenous methadone with initial dose at 0.15 mg/kg in children and 0.2 mg/kg in adolescents.
Drug pages: Fentanyl · Hydromorphone
Per routine care, given as needed
Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit)
Binary (yes/no) need for opioid in the PACU
Time frame: Up to 6 hours post surgery
Total amount of opioid medication administered
Postoperative opioid use expressed in morphine milligram equivalents per kilogram
Time frame: Up to 7 days post surgery
Opioid administration in the PACU (post-anesthesia care unit)
Postoperative opioid use in the recovery room expressed in morphine milligram equivalents per kilogram
Time frame: Up to 6 hours post surgery
Opioid administration post PACU (post-anesthesia care unit)
Postoperative opioid use after PACU discharge expressed in morphine milligram equivalents per kilogram
Time frame: Up to 7 days post surgery
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
Time frame: Up to 7 days post surgery
Number of participants with adverse event in the PACU (post-anesthesia care unit)
Adverse events will only include those that are determined to be related to the study drugs.
Time frame: Up to 6 hours post surgery
Plan to share: Yes — Data will be shared in the NICHD DASH repository.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Per NIH guidelines. Data will be available indefinitely.
Access criteria: NICHD DASH
Data sharing details ↗ · dash.nichd.nih.gov
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Studies of the drugs tested here: Methadone · Fentanyl · Hydromorphone