A Phase 2 interventional study of Fentanyl/Hydromorphone and Methadone in Obstructive Sleep Apnea, Tonsillitis and Pain, Procedural, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 3 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Duke University · Phase 2, 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.
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 66 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive 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.
Counted across the registry records on this site, refreshed daily.
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.
Drug: Fentanyl/Hydromorphone
Drug: Methadone
Drug pages: Fentanyl · Hydromorphone
Per routine care
Initial dosing 0.1mg/kg, potential to escalate to 0.15mg/kg following interim analysis
Total Amount of Opioid Medications Administered
Postoperative opioid medication expressed in oral morphine equivalents (OME) per kilogram
Time frame: Up to 7 days post surgery
Percentage of Scores on the Parent Post Operative Pain Measure (PPPM) That Indicate Clinically Significant Pain
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.
Time frame: Up to 7 days post surgery
NIH PROMIS (Patient-Reported Outcomes Measurement Information System) Parent Proxy Report Scale
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.
Time frame: Up to 7 days post surgery
Evaluation of Participant's Pain as Measured by Numeric Pain Rating Scale
Numeric Pain Rating Scale has a range of 0 to 10, where 0=no pain and 10=worst possible pain.
Time frame: Up to 7 days post surgery
Doses of Prescription Opioid Used Following Hospital Discharge
Number of doses of prescription medication used.
Time frame: Up to 7 days post surgery
Opioid Administration in the PACU (Post-anesthesia Care Unit)
Opioid medication use in the recovery room expressed in oral morphine equivalents (OME) per kilogram.
Time frame: Up to 6 hours post surgery
| Milestone | Short Acting Opioids: Fentanyl, Hydromorphone | Long Acting Opioid: Methadone 0.1mg/kg | Long Acting Opioid: Methadone 0.15mg/kg |
|---|---|---|---|
| Started | 21 | 22 | 23 |
| Completed | 20 | 20 | 20 |
| Not completed | 1 | 2 | 3 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 2 | 2 |
Postoperative opioid medication expressed in oral morphine equivalents (OME) per kilogram
| morphine mg equivalents/kg | Short Acting Opioids: Fentanyl, Hydromorphone | Long Acting Opioid: Methadone (0.1mg/kg) | Long Acting Opioid: Methadone (0.15mg/kg) |
|---|---|---|---|
| Total Amount of Opioid Medications Administered | 1.5 (1.2 to 2.1) | 0.9 (0.1 to 1.4) | 0.5 (0 to 1.4) |
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.
| percentage of PPPM scores | Short Acting Opioids: Fentanyl, Hydromorphone | Long Acting Opioid: Methadone 0.1mg/kg | Long Acting Opioid: Methadone 0.15mg/kg |
|---|---|---|---|
| Percentage of Scores on the Parent Post Operative Pain Measure (PPPM) That Indicate Clinically Significant Pain | 57 | 61 | 63 |
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.
| score on a scale | Short Acting Opioids: Fentanyl, Hydromorphone | Long Acting Opioid: Methadone 0.1mg/kg | Long Acting Opioid: Methadone 0.15mg/kg |
|---|---|---|---|
| NIH PROMIS (Patient-Reported Outcomes Measurement Information System) Parent Proxy Report Scale | 2.4 ± 1.5 | 2.2 ± 1.2 | 2.3 ± 1.1 |
Numeric Pain Rating Scale has a range of 0 to 10, where 0=no pain and 10=worst possible pain.
| score on a scale | Short Acting Opioids: Fentanyl, Hydromorphone | Long Acting Opioid: Methadone (0.1mg/kg) | Long Acting Opioid: Methadone (0.15mg/kg) |
|---|---|---|---|
| Evaluation of Participant's Pain as Measured by Numeric Pain Rating Scale | 4.0 ± 2.5 | 3.7 ± 1.9 | 3.8 ± 2.3 |
Number of doses of prescription medication used.
| doses | Short Acting Opioids: Fentanyl, Hydromorphone | Long Acting Opioid: Methadone (0.1mg/kg) | Long Acting Opioid: Methadone (0.15mg/kg) |
|---|---|---|---|
| Doses of Prescription Opioid Used Following Hospital Discharge | 4 (3 to 9) | 2 (0 to 4) | 3 (0 to 5) |
Opioid medication use in the recovery room expressed in oral morphine equivalents (OME) per kilogram.
| morphine mg equivalents/kg | Short Acting Opioids: Fentanyl, Hydromorphone | Long Acting Opioid: Methadone (0.1mg/kg) | Long Acting Opioid: Methadone (0.15mg/kg) |
|---|---|---|---|
| Opioid Administration in the PACU (Post-anesthesia Care Unit) | 0.15 (0.10 to 0.30) | 0.04 (0 to 0.1) | 0 (0 to 0.1) |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Short Acting Opioids: Fentanyl, Hydromorphone | 0/21 (0%) | 1/21 (4.8%) | 0/21 (0%) |
| Long Acting Opioid: Methadone (0.1mg/kg) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Long Acting Opioid: Methadone (0.15mg/kg) | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Event | Short Acting Opioids: Fentanyl, Hydromorphone | Long Acting Opioid: Methadone (0.1mg/kg) | Long Acting Opioid: Methadone (0.15mg/kg) |
|---|---|---|---|
| Altered mental statusNervous system disorders | 1/21 | 0/22 | 0/23 |
Participants who completed the study.
| Age, Continuous(years) | Short Acting Opioids: Fentanyl, Hydromorphone | Long Acting Opioid: Methadone 0.1mg/kg | Long Acting Opioid: Methadone 0.15mg/kg | Total |
|---|---|---|---|---|
| Median | 4.0 (3.0 to 6.3) | 4.5 (4.0 to 6.3) | 4.5 (3.8 to 7.0) | 4.3 (3.6 to 6.5) |
| Sex: Female, Male(Participants) | Short Acting Opioids: Fentanyl, Hydromorphone | Long Acting Opioid: Methadone 0.1mg/kg | Long Acting Opioid: Methadone 0.15mg/kg | Total |
|---|---|---|---|---|
| Female | 7 | 14 | 9 | 30 |
| Male | 13 | 6 | 11 | 30 |
| Ethnicity (NIH/OMB)(Participants) | Short Acting Opioids: Fentanyl, Hydromorphone | Long Acting Opioid: Methadone 0.1mg/kg | Long Acting Opioid: Methadone 0.15mg/kg | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 3 | 8 |
| Not Hispanic or Latino | 18 | 17 | 17 | 52 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Short Acting Opioids: Fentanyl, Hydromorphone | Long Acting Opioid: Methadone 0.1mg/kg | Long Acting Opioid: Methadone 0.15mg/kg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 2 | 0 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 6 | 10 |
| White | 11 | 18 | 12 | 41 |
| More than one race | 4 | 1 | 1 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Short Acting Opioids: Fentanyl, Hydromorphone | Long Acting Opioid: Methadone 0.1mg/kg | Long Acting Opioid: Methadone 0.15mg/kg | Total |
|---|---|---|---|---|
| United States | 20 | 20 | 20 | 60 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drugs tested here: Fentanyl · Hydromorphone · Methadone