Management of Post-Tonsillectomy Pain in Pediatric Patients

Study Overview
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Brief Summary
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Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.

Official Title
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Effectiveness of a Combined Acetaminophen and Ibuprofen Regimen for Management of Post-Tonsillectomy Pain in Pediatric Patients

Conditions
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Tonsillitis, Pain, Postoperative, Tonsillar Hypertrophy

Intervention / Treatment
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* Drug: Alternating Acetaminophen and Ibuprofen
* Drug: Combined Acetaminophen and Ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 4 to 17 years of age at time of enrollment Undergoing tonsillectomy with or without adenoidectomy Able to provide informed consent from parent or legal guardian Able to provide assent if subject is a minor of appropriate age Exclusion Criteria: Allergy to acetaminophen or ibuprofen Inability for study participant to cooperate with pain assessments Known pregnancy Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center, randomized, open-label, non-inferiority treatment pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alternating Regimen<br>A regimen of acetaminophen and ibuprofen alternating doses every 3 hours. | Drug: Alternating Acetaminophen and Ibuprofen<br>* Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.<br>* Other names: Alternating regimen;|
| Active Comparator: Combined Regimen<br>A regimen of acetaminophen and ibuprofen dosed together every 6 hours. | Drug: Combined Acetaminophen and Ibuprofen<br>* Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.<br>* Other names: Combined regimen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of FLACC pain scores ≥7 from POD 1 through POD 3 | The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 from POD 1 through POD 3 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2. | up to 3 days following consent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of FLACC pain scores ≥7 on each individual POD 1, 3, and 7 | The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 on each individual POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2. | 3 separate individual days, will be completed days after the surgery | 
| Proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7 | The proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2. | up to 7 days following consent | 
| Proportion of Faces pain scores ≥8 on POD 1, 3, and 7 | The proportion of Faces pain scores ≥8 on POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or no hurt, to a crying face at 10, which represents hurts like the worst pain imaginable. Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain. | 3 separate individual days, will be completed days after the surgery | 
| Proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7 | The proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or no hurt, to a crying face at 10, which represents hurts like the worst pain imaginable. Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain. | up to 7 days following consent | 
| Rescue Medication Usage through POD 3 | The proportion of rescue medication usage from POD 1 through POD 3 compared between the combined and the alternating medication regimens. | up to 3 days following consent | 
| Rescue Medication Usage through POD 7 | The proportion of rescue medication usage from POD 1 through POD 7 compared between the combined and the alternating medication regimens. | up to 7 days following consent | 
| Proportion of subjects that adhere to the assigned medication regimen | Proportion of subjects that adhere to the assigned medication regimen compared between the combined and the alternating medication regimens as determined by the medication log that the participants return at the end of the study. | up to 3 days following consent | 
| Adverse Events | Incidence of adverse events | up to 7 days following consent |