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This is a retrospective chart review. The objective of the current study is to determine the analgesic efficacy and side effect profile of intravenous acetaminophen when administered to infants undergoing pyloromyotomy. In addition, recovery characteristics of infants who were administered intravenous acetaminophen will be compared to infants who did not receive intravenous acetaminophen to determine if there were any appreciable differences with regard to postoperative discomfort, PACU time, time to oral feeds and hospital discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Acetaminophen | Acetaminophen administered by intravenous infusion. |
| |
| Rectal Acetaminophen | Acetaminophen administered by rectal suppository. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Acetaminophen given by IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Acetaminophen Dosage | One time in the OR prior to the start of surgery | Baseline |
| Average FLACC Pain Score in the PACU | The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. | 0-60 minutes post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| PACU Time | Time spent in the post-anesthesia care unit post-operatively. | 45-60 minutes post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who presented for pyloromyotomy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Acetaminophen | Acetaminophen given by intravenous infusion. |
| FG001 | Rectal Acetaminophen | Acetaminophen given by rectal suppository. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Acetaminophen | Acetaminophen administered by intravenous infusion. |
| BG001 | Rectal Acetaminophen | Acetaminophen administered by rectal suppository. |
| 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 | Acetaminophen Dosage | One time in the OR prior to the start of surgery | Posted | Mean | Standard Deviation | mg/kg | Baseline |
|
|
During hospital stay following surgery (average 1-3 days).
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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 | IV Acetaminophen | Acetaminophen administered by intravenous infusion. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arlyne Thung | Nationwide Children's Hospital - Dept. of Anesthesiology & Pain Medicine | 614-722-4200 | Arlyne.Thung@nationwidechildrens.org |
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| ID | Term |
|---|---|
| D011707 | Pyloric Stenosis |
| ID | Term |
|---|---|
| D017219 | Gastric Outlet Obstruction |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Acetaminophen | Drug | Acetaminophen suppository given rectally |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | days |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Primary | Average FLACC Pain Score in the PACU | The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. | Posted | Mean | Standard Deviation | units on a scale 0-10 | 0-60 minutes post-operatively |
|
|
|
| Secondary | PACU Time | Time spent in the post-anesthesia care unit post-operatively. | Posted | Mean | Standard Deviation | minutes | 45-60 minutes post-operatively |
|
|
|
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Rectal Acetaminophen | Acetaminophen administered by rectal suppository. | 0 | 34 | 0 | 34 | 0 | 34 |
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| Aniline Compounds |
| D000588 | Amines |