Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine if a post-operative course of oral dexamethasone affects opioid usage in pediatric patients undergoing tonsillectomy. Patients who are scheduled to undergo tonsillectomy or adenotonsillectomy are randomized to receive either 1) a post-operative steroid course of oral dexamethasone in addition opioids, acetaminophen,NSAIDs or 2) opioids/acetaminophen/NSAIDS alone. All drugs are prescribed per approved FDA labeling. Children between the ages of 4-17 will be considered for enrollment. Participants (or with the aid of parents/legal guardian for subjects unable to complete on their own) will complete a diary twice a day to record pain medication administration and visual pain scale. Remaining steroid and opioid medication will be measured at the routine post-operative appointment that occurs 4 - 6 weeks following surgery.

Official Title
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A Randomized Control Trial of Post-operative Course of Oral Dexamethasone and Effect on Opioid Usage in Pediatric Tonsillectomies in a Tertiary Care Center

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Analgesics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 4-17 years at time of surgery Scheduled for tonsillectomy or adenotonsillectomy surgery Exclusion Criteria: Prior history of intracapsular tonsillectomy Previous diagnoses of Down Syndrome or developmental delay Presence of gastrostomy (g) tube A contraindication to steroids or steroid usage within 30 days prior to surgery including diabetes, allergy to steroid, already on chronic steroid, immune deficiency Active infection or concurrent operative procedures at the time of surgery Unable to read or speak English Pregnant or breastfeeding females

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone plus analgesics<br>oral dexamethasone of 0.5mg/kg/day (max of 8mg/day), administered on post-operative days 1,3,5,7 in addition to standardized course of analgesics (opioids/acetaminophen/NSAIDs). | Drug: Dexamethasone<br>* dexamethasone solution or tablet (depending on age of patient) at 0.5mg/kg/day max of 8mg/day, administered on post-operative days 1,3,5,7.<br>Drug: Analgesics<br>* standardization of post-operative analgesics (narcotics and non-narcotic medication). Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication) Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)<br>|
| Active Comparator: analgesics alone<br>standardized course of analgesics (opioids/acetaminophen/NSAIDs) | Drug: Analgesics<br>* standardization of post-operative analgesics (narcotics and non-narcotic medication). Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication) Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use | measured by medication log and units remaining | 4 weeks post-op | 
| change in pain score | measured by a visual analog scale, where 0 is no pain and 10 is worst possible pain. | twice daily from surgery to 14 days post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of post-operative complications | Measured by post-op re-admissions and emergency room visits | 30 days post-op |