IV Acetaminophen and Post-Tonsillectomy Pain
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|ClinicalTrials.gov Identifier: NCT03883893|
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tonsillectomy Adenoidectomy||Drug: Intravenous acetaminophen Other: Normal saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Clinical research coordinator, parent and participant will be masked until participant is discharged from hospital. OR staff will not be masked.|
|Official Title:||Randomized Prospective Study Investigating the Analgesic Efficacy of Intravenous Acetaminophen in Reducing Post-Tonsillectomy Pain in Pediatric Patients|
|Estimated Study Start Date :||April 2020|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||April 2023|
Active Comparator: IV Tylenol
Participants will receive IV acetaminophen 15mg/kg in the OR.
Drug: Intravenous acetaminophen
Intravenous acetaminophen will be given in the OR.
Other Name: IV Tylenol
Placebo Comparator: Normal Saline
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.
Other: Normal saline
Normal saline will given if randomized to this group.
- Post-operative pain scores [ Time Frame: Every 5 minutes after awake in recovery room for 30 minutes ]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
- Quality of emergence from anesthesia [ Time Frame: When first spontaneous eye movement occurs in recovery room ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883893
|Contact: Judy Audas, APRN-CRNA,MSNfirstname.lastname@example.org|
|Contact: Kristie Geisler, BSemail@example.com|
|Principal Investigator:||Judy Audas, APRN-CRNA,MSN||Children's Hospital Medical Center, Cincinnati|