IV Acetaminophen and Post-Tonsillectomy Pain

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Prospective Study Investigating the Analgesic Efficacy of Intravenous Acetaminophen in Reducing Post-Tonsillectomy Pain in Pediatric Patients

Conditions
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Tonsillectomy, Adenoidectomy

Intervention / Treatment
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* Drug: Intravenous acetaminophen
* Other: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is age 3 to 10 years (inclusive) The subject weighs more than 10.0 kg (inclusive of the tenth kilogram) The subject is scheduled for the following: Elective tonsillectomy or tonsillectomy with adenoidectomy scheduled on an outpatient basis, with acceptable inclusion of patients also having PETs and/or EUA of ear The subject is ASA patient classification I-II The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate. Exclusion Criteria: Additional surgical procedures are being performed concurrently; The subject is ASA classification > II; The subject has pre-existing allergy or known hypersensitivity to acetaminophen; The subject receives midazolam as a premedication; The subject has a history of chronic malnutrition; The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV Tylenol<br>Participants will receive IV acetaminophen 15mg/kg in the OR. | Drug: Intravenous acetaminophen<br>* Intravenous acetaminophen will be given in the OR.<br>* Other names: IV Tylenol;|
| Placebo Comparator: Normal Saline<br>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<br>* Normal saline will given if randomized to this group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | When first spontaneous eye movement occurs in recovery room | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tonsillectomy, Intravenous Acetaminophen, Pediatric