Obstructive Sleep ApneaPhase 2NCT05244226
Pediatric Pain Optimization After Tonsillectomy
A Phase 2 study testing Fentanyl/Hydromorphone and Methadone in people with Obstructive Sleep Apnea and Tonsillitis, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Tonsillitis, Pain, Procedural
- What is being tested?
- Fentanyl/Hydromorphone and Methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2022to 10 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children ages 3 to 17 years old
- Presenting for elective tonsillectomy +/- adenoidectomy
- Provide informed consent / assent (as appropriate)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University School of Medicine
Durham, North Carolina, 27710
About this study
Official title: Pediatric Pain Optimization After Tonsillectomy: A Randomized Double Blind Methadone Pilot Study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Tonsillitis, Pain, Procedural
- Being tested
- Fentanyl/Hydromorphone, Methadone
- Medical subject headings
- Sleep Apnea, Obstructive, Tonsillitis, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl/HydromorphoneDrug
Per routine care
MethadoneDrug
Initial dosing 0.1mg/kg, potential to escalate to 0.15mg/kg following interim analysis
| Study group | Role | What they receive |
|---|---|---|
| Short acting opioids: Fentanyl, Hydromorphone | Active comparator | Not described Receives: Drug: Fentanyl/Hydromorphone |
| Long Acting Opioid: Methadone | Active comparator | Not described Receives: Drug: Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Amount of Opioid Medications Administered
Postoperative opioid medication expressed in oral morphine equivalents (OME) per kilogram
Measured: Up to 7 days post surgery
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Up to 7 days post surgery
Doses of Prescription Opioid Used Following Hospital Discharge
Number of doses of prescription medication used.
Measured: 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.
Measured: Up to 6 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start8 Apr 2022
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa M Einhorn, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244226
- Sponsor's protocol ID
- Pro00109911
- Status last verified
- Oct 2024
- First submitted
- 8 Feb 2022
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38669011
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Pain Optimization After Tonsillectomy: A Randomized Double Blind Methadone Pilot Study
- ClinicalTrials.gov ID
- NCT05244226
- Acronym / sponsor ID
- Pro00109911
- Conditions
- Obstructive Sleep Apnea, Tonsillitis, Pain, Procedural
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short acting opioids: Fentanyl, Hydromorphone | Active comparator | Drug: Fentanyl/Hydromorphone |
| Long Acting Opioid: Methadone | Active comparator | Drug: Methadone |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children ages 3 to 17 years old
- Presenting for elective tonsillectomy +/- adenoidectomy
- Provide informed consent / assent (as appropriate)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl/HydromorphonePer routine care | Drug | Short acting opioids: Fentanyl, Hydromorphone |
| MethadoneInitial dosing 0.1mg/kg, potential to escalate to 0.15mg/kg following interim analysis | Drug | Long Acting Opioid: Methadone |
Primary outcome
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
5 secondary outcomes
Percentage of Scores on the Parent Post Operative Pain Measure (PPPM) That Indicate Clinically Significant Pain
Time frame: Up to 7 days post surgery
NIH PROMIS (Patient-Reported Outcomes Measurement Information System) Parent Proxy Report Scale
Time frame: Up to 7 days post surgery
Evaluation of Participant's Pain as Measured by Numeric Pain Rating Scale
Time frame: Up to 7 days post surgery
Doses of Prescription Opioid Used Following Hospital Discharge
Time frame: Up to 7 days post surgery
Opioid Administration in the PACU (Post-anesthesia Care Unit)
Time frame: Up to 6 hours post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38669011Einhorn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M Einhorn, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fentanyl/Hydromorphone and Methadone in people with Obstructive Sleep Apnea and Tonsillitis, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Amount of Opioid Medications Administered (time frame: Up to 7 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05244226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.