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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short acting opioids: Fentanyl, Hydromorphone | Active Comparator |
| |
| Long Acting Opioid: Methadone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl/Hydromorphone | Drug | Per routine care |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Amount of Opioid Medications Administered | Postoperative opioid medication expressed in oral morphine equivalents (OME) per kilogram | Up to 7 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 7 days post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M Einhorn, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University School of Medicine | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38669011 | Result | Einhorn LM, Hoang J, La JO, Kharasch ED. Single-dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double-blind Clinical Trial. Anesthesiology. 2024 Sep 1;141(3):463-474. doi: 10.1097/ALN.0000000000005031. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Short Acting Opioids: Fentanyl, Hydromorphone | Fentanyl/Hydromorphone: Per routine care |
| FG001 | Long Acting Opioid: Methadone 0.1mg/kg | Low dose methadone: 0.1mg/kg |
| FG002 | Long Acting Opioid: Methadone 0.15mg/kg | High dose methadone: 0.15 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Short Acting Opioids: Fentanyl, Hydromorphone | Fentanyl/Hydromorphone: Per routine care |
| BG001 | Long Acting Opioid: Methadone 0.1mg/kg | Low dose methadone: 0.1mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Amount of Opioid Medications Administered | Postoperative opioid medication expressed in oral morphine equivalents (OME) per kilogram | Posted | Median | Inter-Quartile Range | morphine mg equivalents/kg | Up to 7 days post surgery |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Short Acting Opioids: Fentanyl, Hydromorphone | Fentanyl/Hydromorphone: Per routine care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered mental status | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Einhorn, MD | Duke University | 919-681-4877 | lisa.einhorn@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2022 | Mar 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D014069 | Tonsillitis |
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D004091 | Hydromorphone |
| D008691 | Methadone |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
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| Methadone |
| Drug |
Initial dosing 0.1mg/kg, potential to escalate to 0.15mg/kg following interim analysis |
|
| 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. | 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. | Up to 7 days post surgery |
| Doses of Prescription Opioid Used Following Hospital Discharge | Number of doses of prescription medication used. | 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. | Up to 6 hours post surgery |
| Protocol Violation |
|
| BG002 | Long Acting Opioid: Methadone 0.15mg/kg | High dose methadone: 0.15mg/kg |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
High dose methadone: 0.15 mg/kg
|
|
|
| Secondary | 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. | Participants who were less than 13 years of age. Each participant reported 7 scores. | Posted | Number | percentage of PPPM scores | Up to 7 days post surgery | PPPM scores | PPPM scores |
|
|
|
| Secondary | 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. | Participants who were less than 13 years of age. | Posted | Mean | Standard Deviation | score on a scale | Up to 7 days post surgery |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 7 days post surgery |
|
|
|
| Secondary | Doses of Prescription Opioid Used Following Hospital Discharge | Number of doses of prescription medication used. | Posted | Median | Inter-Quartile Range | doses | 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 oral morphine equivalents (OME) per kilogram. | Posted | Median | Inter-Quartile Range | morphine mg equivalents/kg | Up to 6 hours post surgery |
|
|
|
|
| 0 |
| 21 |
| 1 |
| 21 |
| 0 |
| 21 |
| EG001 | Long Acting Opioid: Methadone (0.1mg/kg) | Low dose methadone: 0.1mg/kg | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | Long Acting Opioid: Methadone (0.15mg/kg) | High dose methadone: 0.15 mg/kg | 0 | 23 | 0 | 23 | 0 | 23 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009019 |
| Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| Superiority |
| 0.021 |
| Superiority |