Dexamethasone and Post-tonsillectomy Pain in Children

Study Overview
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Brief Summary
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The investigators will use a prospective randomized, controlled design utilizing a single preoperative dose of oral dexamethasone or placebo to achieve these specific aims: Specific Aim 1: To evaluate the potential for a single preoperative dose of oral dexamethasone administered the night before surgery to reduce the incidence and severity of early post tonsillectomy pain (PTP) in children Specific Aim 2: To prospectively evaluate differences in early PTP experience between overweight/obese children and their lean peers. Specific Aim 3: To determine whether circulating inflammatory markers are strongly linked to PTP severity in children and whether they could be potential contributors to the higher pain experienced by overweight/obese children following Tonsillectomy and or Adenoidectomy.

Detailed Description
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(See brief summary as well) The study will serve as a vehicle for a three-pronged approach (clinical observation, biological basis and therapeutic intervention) reflects the applicants professional interest in translational pediatric obesity research If the investigators find that BMI-dependent disparity exists in Post Tonsillectomy Pain (PTP) and that preoperative down regulation of inflammatory response with one preoperative dose of corticosteroids reduces PTP, our findings should ultimately lead to improved postoperative pain management of pediatric PTP especially in obese children.

Official Title
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Does Dexamethasone Reduce Postoperative Pain in Pediatric Tonsillectomy Patients?

Conditions
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Pediatric Post-tonsillectomy Pain

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for tonsillectomy and/or adenoidectomy at University of Michigan, C. S. Mott Children's Hospital Exclusion Criteria: Known hypersensitivity to dexamethasone Developmental delay Taking chronic analgesics Taking chronic systemic steroids Treatment with steroids in last 30 days Cushings or Prader-Willi or Nephrotic Syndromes Diabetes Mellitus

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>Liquid or capsule dexamethasone - to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy | Drug: Dexamethasone<br>* Oral dexamethasone elixir (0.5mg/ml or 4 mg/ml) mixed with Ora-sweet or simple syrup to mask the taste. Or 1 mg or 4 mg dexamethasone capsules if age appropriate<br>* Other names: corticosteroid;|
| Placebo Comparator: Placebo<br>Placebo liquid or capsule to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy | Drug: Placebo<br>* Placebo liquid (Ora-sweet or simple syrup) or Placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of moderate/severe pain(>/= 4 of 10 using the Wong-Baker faces Scale) during recovery room stay | Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit. | 0-8 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients requiring analgesic intervention in the PACU will differ by BMI category (normal, overweight and obese). | Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit. | 0-8 hours postoperatively | 
| Bivariate association between BMI (in Kg/m2) and serum values of inflammatory markers (CRP, TNF-alpha and IL-6) will be computed. | Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit. | 0-8 hours postoperatively |