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Acetaminophen is frequently used as an adjunct for pain management in pediatric surgical patients. The drug is available in an over the counter, inexpensive oral form as well as a considerably more expensive intravenous form. This study will compare opioid requirements and acetaminophen plasma levels post operatively for two dosing regimens to compare oral versus intravenous routes given pre operatively.
The primary purpose of this study is to compare opioid utilization in post-operative patients undergoing tonsillectomy and adenoidectomy, between IV and PO acetaminophen. Secondarily, it will provide information regarding possible cost savings, pharmacokinetics and safety between these two regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Acetaminophen | Experimental | Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision. |
|
| Intravenous Acetaminophen | Experimental | Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | already included in arm/group descriptions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Dose of Opioid | Total dose of opioid, in morphine equivalents, that the patient receives for breakthrough pain in the 24 hour period following surgery. | Within 24hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Severe Pain Score of 7 or Higher | A secondary endpoint is the proportion of patients with pain scores in the severe pain range (7 or higher) on numeric pain rating scale of 0 to 10; higher score more severe. | 24 hrs period following surgery |
| Plasma Acetaminophen Level 1 - End of Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cathy Lammers, MD | UC Davis Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Children's Hospital | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34304234 | Derived | Lammers CR, Schwinghammer AJ, Hall B, Kriss RS, Aizenberg DA, Funamura JL, Senders CW, Nittur V, Applegate RL 2nd. Comparison of Oral Loading Dose to Intravenous Acetaminophen in Children for Analgesia After Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial. Anesth Analg. 2021 Dec 1;133(6):1568-1576. doi: 10.1213/ANE.0000000000005678. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Acetaminophen | Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision. Acetaminophen |
| FG001 | Intravenous Acetaminophen | Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision. Acetaminophen |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Completed subjects (n=66) used for analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Acetaminophen | Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision. Acetaminophen |
| BG001 | Intravenous Acetaminophen |
| 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 Dose of Opioid | Total dose of opioid, in morphine equivalents, that the patient receives for breakthrough pain in the 24 hour period following surgery. | Posted | Median | Inter-Quartile Range | mcg/kg | Within 24hrs |
|
24 hours
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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 | Oral Acetaminophen | Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision. Acetaminophen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard L. Applegate II MD | UC Davis Anesthesiology & Pain Medicine | 916-734-5028 | rapplegate@ucdavis.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 | Nov 18, 2016 | Nov 3, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 2, 2017 | Nov 3, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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mg/L acetaminophen in the plasma at the end of surgery |
| at the end of surgery, about 1 hour after IV Dose |
| Plasma Acetaminophen Level 2 - 3 Hours After IV Study Drug Administration | mg/L acetaminophen in the plasma 3 hours after IV study drug administration | Outcome will be measured 3hrs post first IV Dose |
| Did not receive study medications: red dye allergy |
|
Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision. Acetaminophen |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| Weight (kg) | Median | Inter-Quartile Range | kg |
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| Percentile weight for age | Median | Inter-Quartile Range | percentile |
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| Secondary | Proportion of Patients With Severe Pain Score of 7 or Higher | A secondary endpoint is the proportion of patients with pain scores in the severe pain range (7 or higher) on numeric pain rating scale of 0 to 10; higher score more severe. | Posted | Count of Participants | Participants | 24 hrs period following surgery |
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|
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| Secondary | Plasma Acetaminophen Level 1 - End of Surgery | mg/L acetaminophen in the plasma at the end of surgery | 2 patients in Oral did not have sample obtained for level; 1 patient in IV had value below 10 mg/L limit of quantification | Posted | Median | Inter-Quartile Range | mg/L | at the end of surgery, about 1 hour after IV Dose |
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| Secondary | Plasma Acetaminophen Level 2 - 3 Hours After IV Study Drug Administration | mg/L acetaminophen in the plasma 3 hours after IV study drug administration | Acetaminophen plasma levels obtained 3 hours after start of the IV study drug in patients with samples obtained; these were not available for 8 Oral and 9 IV subjects. | Posted | Median | Inter-Quartile Range | mg/L | Outcome will be measured 3hrs post first IV Dose |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Intravenous Acetaminophen | Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision. Acetaminophen | 0 | 36 | 0 | 36 | 0 | 36 |
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| Aniline Compounds |
| D000588 | Amines |