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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002345 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl | Active Comparator |
| |
| Hydromorphone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone | Drug | Patients will be randomized to one of two opioids for the treatment of post-operative pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Requiring Rescue Intravenous Opioid | Number | up to 6 hours post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Montana, MD PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine/Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23382017 | Background | Friedman NR, Perkins JN, McNair B, Mitchell RB. Current practice patterns for sleep-disordered breathing in children. Laryngoscope. 2013 Apr;123(4):1055-8. doi: 10.1002/lary.23709. Epub 2013 Feb 4. | |
| 21539679 | Background | Brown KA. Outcome, risk, and error and the child with obstructive sleep apnea. Paediatr Anaesth. 2011 Jul;21(7):771-80. doi: 10.1111/j.1460-9592.2011.03597.x. Epub 2011 May 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydromorphone | Pediatric patients will be randomized to one of two arms. Arm 1 will receive intravenous hydromorphone intraoperatively following induction of general anesthesia. Arm 2 will receive intravenous fentanyl in the operating room following induction of general anesthesia. |
| FG001 | Fentanyl | Pediatric patients will be randomized to one of two arms. Arm 1 will receive intravenous hydromorphone intraoperatively following induction of general anesthesia. Arm 2 will receive intravenous fentanyl in the operating room following induction of general anesthesia. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydromorphone | Pediatric patients randomized to receive hydromorphone intravenously in the operating room. |
| BG001 | Fentanyl | Pediatric patients randomized to receive fentanyl intravenously in the operating room. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Patients Requiring Rescue Intravenous Opioid | Number | Posted | Count of Participants | Participants | up to 6 hours post surgery |
|
|
2 weeks
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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 | Hydromorphone | Pediatric patients will be randomized to receive one of either hydromorphone or fentanyl intravenously in the operating room. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative tonsillar bleed | Blood and lymphatic system disorders | Non-systematic Assessment | 5 patients with postoperative tonsillar bleed (2 in the hydromorphone arm, 3 in the fentanyl arm) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Greg Miller | Washington University | 314-454-6000 | g.c.miller@wustl.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 | Mar 26, 2020 | May 10, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 22, 2020 | May 10, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D014069 | Tonsillitis |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Fentanyl | Drug | Fentanyl |
|
| Evaluation of Participant's SpO2 Saturation | SpO2 % | 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 | up to 6 hours following surgery |
| Respiratory and PONV Events at Home | Survey sent to parent by email postoperatively | up to 7 days following surgery |
| 20974339 | Background | Bhattacharyya N, Lin HW. Changes and consistencies in the epidemiology of pediatric adenotonsillar surgery, 1996-2006. Otolaryngol Head Neck Surg. 2010 Nov;143(5):680-4. doi: 10.1016/j.otohns.2010.06.918. |
| 42312422 | Derived | Miller GC, Hifko AJ, Lieu JK, Nguyen JT, Lieu JEC, Montana MC. A Triple-Blinded, Randomized, Controlled Trial Comparing Hydromorphone vs. Fentanyl for Children Undergoing Tonsillectomy. Paediatr Anaesth. 2026 Jun 18. doi: 10.1002/pan.70240. Online ahead of print. |
| IV inadvertently removed |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU. |
|
|
|
| Secondary | Evaluation of Participant's SpO2 Saturation | SpO2 % | Posted | Mean | Standard Deviation | percentage of SpO2 saturation | Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU. |
|
|
|
| Secondary | Respiratory and PONV Events in PACU | Posted | Count of Participants | Participants | up to 6 hours following surgery |
|
|
|
| Secondary | Respiratory and PONV Events at Home | Survey sent to parent by email postoperatively | Posted | Count of Participants | Participants | up to 7 days following surgery |
|
|
|
| 0 |
| 90 |
| 0 |
| 90 |
| 15 |
| 90 |
| EG001 | Fentanyl | Pediatric patients will be randomized to receive one of either hydromorphone or fentanyl intravenously in the operating room. | 0 | 90 | 0 | 90 | 12 | 90 |
|
| Fever | Infections and infestations | Non-systematic Assessment |
|
| Prolonged admission for poor oral intake | Gastrointestinal disorders | Non-systematic Assessment |
|
| Tongue Injury | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Readmitted for urinary retention | Renal and urinary disorders | Non-systematic Assessment |
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| Readmitted for nausea or vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Prolonged admission for nausea or vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Postoperative Hypotension | Vascular disorders | Non-systematic Assessment |
|
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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 |
| D006571 |
| Heterocyclic Compounds |
| 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 |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| 10min |
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| 15min |
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| 30min |
|
| 45min |
|
| 60min |
|
| 10min |
|
| 15min |
|
| 30min |
|
| 45min |
|
| 60min |
|
| PONV in PACU |
|
| No events |
|
| Problems breathing since discharge |
|
| No events |
|