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This proposed study will assess analgesic efficacy of a multi-modal, non-opioid analgesic regimen for providing surgical analgesia in pediatric patients undergoing adenoidectomy and to assess recovery characteristics in the post-anesthesia care unit (PACU) and at home following surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-opiod pain relief | Experimental | Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextromethorphan | Drug | Preoperative oral dextromethorphan 1 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Score | Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU). | 1 hr post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Extubation Time | Amount of time in the PACU before patient is ready to be extubated. | 1 hr post-op |
| Time in PACU | Total time in PACU before patient met discharge criteria. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arlyne Thung, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-opiod Pain Relief | Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine. Dextromethorphan: Preoperative oral dextromethorphan 1 mg/kg Acetaminophen: Preoperative oral acetaminophen 15 mg/kg Dexmedetomidine: Intraoperative intravenous dexmedetomidine 0.5 μg/kg Ketamine: Intraoperative intravenous ketamine 0.5 mg/kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-opiod Pain Relief | Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine. Dextromethorphan: Preoperative oral dextromethorphan 1 mg/kg Acetaminophen: Preoperative oral acetaminophen 15 mg/kg Dexmedetomidine: Intraoperative intravenous dexmedetomidine 0.5 μg/kg Ketamine: Intraoperative intravenous ketamine 0.5 mg/kg |
| 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 | Average Pain Score | Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU). | Posted | Mean | Standard Deviation | pain score | 1 hr post-op |
|
|
72 hours post-op
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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 | Non-opiod Pain Relief | Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine. Dextromethorphan: Preoperative oral dextromethorphan 1 mg/kg Acetaminophen: Preoperative oral acetaminophen 15 mg/kg Dexmedetomidine: Intraoperative intravenous dexmedetomidine 0.5 μg/kg Ketamine: Intraoperative intravenous ketamine 0.5 mg/kg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arlyne Thung, MD | Nationwide Children's Hospital | 614-722-4200 | Arlyne.Thung@nationwidechildrens.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 8, 2019 | Dec 29, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003915 | Dextromethorphan |
| D000111 | Acetylcysteine |
| D000082 | Acetaminophen |
| D020927 | Dexmedetomidine |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Acetaminophen | Drug | Preoperative oral acetaminophen 15 mg/kg |
|
|
| Dexmedetomidine | Drug | Intraoperative intravenous dexmedetomidine 0.5 μg/kg |
|
|
| Ketamine | Drug | Intraoperative intravenous ketamine 0.5 mg/kg |
|
|
| 1-2 hr post-op |
| Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations | Presence of sedation, nausea/vomiting, or hallucinations post-operatively. | 2 hours post-op |
| End of Surgery to Hospital Discharge | Length of time before patient is ready to be discharged home. | 2-3 hours post-op |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Median | Inter-Quartile Range | kilograms |
|
| Height | Median | Inter-Quartile Range | centimeters |
|
| ASA 1 | The American Society of Anesthesiologists (ASA) physical status classification 1 = normal healthy patient | Number | participants |
|
| ASA 2 | The American Society of Anesthesiologists (ASA) physical status classification 2 = patient with mild systemic disease | Number | participants |
|
| Participants |
|
|
| Secondary | Extubation Time | Amount of time in the PACU before patient is ready to be extubated. | Posted | Median | Inter-Quartile Range | minutes | 1 hr post-op |
|
|
|
| Secondary | Time in PACU | Total time in PACU before patient met discharge criteria. | Posted | Median | Inter-Quartile Range | minutes | 1-2 hr post-op |
|
|
|
| Secondary | Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations | Presence of sedation, nausea/vomiting, or hallucinations post-operatively. | Posted | Number | participants | 2 hours post-op |
|
|
|
| Secondary | End of Surgery to Hospital Discharge | Length of time before patient is ready to be discharged home. | Posted | Median | Inter-Quartile Range | minutes | 2-3 hours post-op |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| 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 |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Title | Measurements |
|---|---|
|