An Early Phase 1 interventional study of Hydromorphone and Fentanyl in Obstructive Sleep Apnea and Tonsillitis, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 2 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Washington University School of Medicine · Early Phase 1, Interventional, and Treatment
A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.
This is a randomized clinical trial with masked assessment, comparing recovery indices for patients receiving intermediate acting versus short acting opioid analgesia using hydromorphone or fentanyl as intraoperative analgesics. An otherwise standardized anesthetic and analgesic regimen will be utilized, consistent with routine care at SLCH. Patients will be randomized 1:1 in block sizes of 5 per group. Patients will be randomized to receive either hydromorphone or fentanyl throughout the perioperative period by opening a sealed protocol envelope.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 189 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) 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.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
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.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Hydromorphone
Patients will be randomized to one of two opioids for the treatment of post-operative pain.
Fentanyl
Number of Patients Requiring Rescue Intravenous Opioid
Number
Time frame: up to 6 hours post surgery
Evaluation of Participant's Pain
Revised Face, Legs, Activity, Cry, Consolability (rFLACC) Scale Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0=no pain/relaxed, 10=distressed/in pain
Time frame: Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.
Evaluation of Participant's SpO2 Saturation
SpO2 %
Time frame: Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.
Respiratory and PONV Events in PACU
Time frame: up to 6 hours following surgery
Respiratory and PONV Events at Home
Survey sent to parent by email postoperatively
Time frame: up to 7 days following surgery
| Milestone | Hydromorphone | Fentanyl |
|---|---|---|
| Started | 93 | 95 |
| Completed | 90 | 90 |
| Not completed | 3 | 5 |
| Withdrew: Physician decision | 2 | 3 |
| Withdrew: Investigational pharmacy unable to provide medications in timely manner | 1 | 1 |
| Withdrew: Iv inadvertently removed | 0 | 1 |
Number
| Participants | Hydromorphone | Fentanyl |
|---|---|---|
| Number of Patients Requiring Rescue Intravenous Opioid | 48 | 66 |
Revised Face, Legs, Activity, Cry, Consolability (rFLACC) Scale Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0=no pain/relaxed, 10=distressed/in pain
| score on a scale | Hydromorphone | Fentanyl |
|---|---|---|
| 0min | 2.8 ± 3.5 | 4.3 ± 3.9 |
| 5min | 2.7 ± 3.5 | 3.7 ± 3.9 |
| 10min | 2.3 ± 3.1 | 3.5 ± 3.6 |
| 15min | 2.3 ± 2.5 | 3.4 ± 3.3 |
| 30min | 1.7 ± 2.6 | 2.7 ± 2.9 |
| 45min | 0.7 ± 1.4 | 2.4 ± 2.4 |
| 60min | 0.5 ± 1.1 | 2.1 ± 2.0 |
SpO2 %
| percentage of SpO2 saturation | Hydromorphone | Fentanyl |
|---|---|---|
| 0min | 96.9 ± 2.7 | 96.6 ± 2.7 |
| 5min | 97.3 ± 2.8 | 96.1 ± 9.6 |
| 10min | 97.4 ± 2.2 | 97.3 ± 2.5 |
| 15min | 97.1 ± 2.7 | 97.7 ± 2.1 |
| 30min | 96.9 ± 2.1 | 96.8 ± 9.0 |
| 45min | 96.8 ± 2.2 | 97.6 ± 1.7 |
| 60min | 96.7 ± 2.3 | 97.4 ± 2.0 |
| Participants | Hydromorphone | Fentanyl |
|---|---|---|
| Witnessed apnea in PACU | 3 | 4 |
| Witnessed desaturation below 90% in PACU | 9 | 11 |
| PONV in PACU | 1 | 2 |
| No events | 77 | 73 |
Survey sent to parent by email postoperatively
| Participants | Hydromorphone | Fentanyl |
|---|---|---|
| Nausea since discharge | 10 | 13 |
| Vomiting since discharge | 7 | 9 |
| Problems breathing since discharge | 1 | 2 |
| No events | 46 | 35 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hydromorphone | 0/90 (0%) | 0/90 (0%) | 15/90 (16.7%) |
| Fentanyl | 0/90 (0%) | 0/90 (0%) | 12/90 (13.3%) |
| Event | Hydromorphone | Fentanyl |
|---|---|---|
| Prolonged admission for poor oral intakeGastrointestinal disorders | 8/90 | 3/90 |
| Postoperative tonsillar bleedBlood and lymphatic system disorders | 2/90 | 3/90 |
| Readmitted for nausea or vomitingGastrointestinal disorders | 1/90 | 2/90 |
| Prolonged admission for nausea or vomitingGastrointestinal disorders | 1/90 | 2/90 |
| FeverInfections and infestations | 1/90 | 1/90 |
| Tongue InjurySkin and subcutaneous tissue disorders | 0/90 | 1/90 |
| Readmitted for urinary retentionRenal and urinary disorders | 1/90 | 0/90 |
| Postoperative HypotensionVascular disorders | 1/90 | 0/90 |
| Age, Categorical(Participants) | Hydromorphone | Fentanyl | Total |
|---|---|---|---|
| <=18 years | 90 | 90 | 180 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Hydromorphone | Fentanyl | Total |
|---|---|---|---|
| Female | 36 | 40 | 76 |
| Male | 54 | 50 | 104 |
| Ethnicity (NIH/OMB)(Participants) | Hydromorphone | Fentanyl | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 6 |
| Not Hispanic or Latino | 86 | 87 | 173 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Hydromorphone | Fentanyl | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 3 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 19 | 19 | 38 |
| White | 68 | 67 | 135 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2020 to primary completion in Apr 2022, 25 months.
Results were first posted in Dec 2024, 2 years 8 months after primary completion.
Of 27 phase 1 interventional studies under Sleep Apnea, Obstructive, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 44. This study's 25 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Hydromorphone · Fentanyl
Washington University School of Medicine →