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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23GM104354 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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:
(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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Experimental | Liquid or capsule dexamethasone - to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy |
|
| Placebo | Placebo Comparator | Placebo liquid or capsule to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olubukola Nafiu, MD | University of Michigan, CS Mott Children's Hospital, Dept of Otolaryngology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| Placebo | Drug | Placebo liquid (Ora-sweet or simple syrup) or Placebo capsule |
|
Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit. |
| 0-8 hours postoperatively |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |