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Mentor for PI left institution. Study was not renewed.
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This study is a randomized prospective study to compare the post-operative analgesic efficacy of intravenous acetaminophen 15 mg/kg to an equal volume of 0.9% normal saline when all other analgesic interventions have been standardized for all patients enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Tylenol | Active Comparator | Participants will receive IV acetaminophen 15mg/kg in the OR. |
|
| Normal Saline | Placebo Comparator | Participants will receive 0.9% normal saline in the OR. The amount received will be equivalent of what would be given if they were receiving IV acetaminophen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous acetaminophen | Drug | Intravenous acetaminophen will be given in the OR. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain scores | FLACC (Face, Legs, Activity, Cry, Consolability) behavior scale Each area measured is graded 0 - 2 and then totaled. Total score will range from 0 - 10. A total score of 0 - patient is relaxed and comfortable, 1 - 3 - patient is mildly uncomfortable, 4 - 6 - patient is in moderate pain, 7 - 10 - patient is having severe discomfort/pain | Every 5 minutes after awake in recovery room for 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of emergence from anesthesia | Pediatric Anesthesia Emergence Delirium scale (PAED) This scale uses 5 criteria to determine the extent of emergence delirium in children. "The child makes eye contact with the caregiver", "The child's actions are purposeful", The child is aware of his/her surroundings", The child is restless" and "The child is inconsolable." Each of these 5 catagories are scored on a 0-4 scale. The higher the total number the greater the extent of the emergence delirium. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judy Audas, APRN-CRNA,MSN | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Clinical research coordinator, parent and participant will be masked until participant is discharged from hospital. OR staff will not be masked.
| Normal saline | Other | Normal saline will given if randomized to this group. |
|
| When first spontaneous eye movement occurs in recovery room |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |