Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
137 participants
INTERVENTIONAL
2016-06-30
2019-06-27
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dexamethasone
Liquid or capsule dexamethasone - to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy
Dexamethasone
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
Placebo
Placebo liquid or capsule to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy
Placebo
Placebo liquid (Ora-sweet or simple syrup) or Placebo capsule
Interventions
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Dexamethasone
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
Placebo
Placebo liquid (Ora-sweet or simple syrup) or Placebo capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
4 Years
17 Years
ALL
No
Sponsors
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National Institute of General Medical Sciences (NIGMS)
NIH
Nationwide Children's Hospital
OTHER
Responsible Party
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Olubukola Nafiu
Assistant Professor of Anesthesiology, University of Michigan Medical School
Principal Investigators
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Olubukola Nafiu, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan, CS Mott Children's Hospital, Dept of Otolaryngology
Locations
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University of Michigan C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00084860
Identifier Type: -
Identifier Source: org_study_id
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