Pediatric Post-tonsillectomy Pain
Conditions
Brief summary
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
(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.
Interventions
DRUGDexamethasone
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
DRUGPlacebo
Placebo liquid (Ora-sweet or simple syrup) or Placebo capsule
Sponsors
National Institute of General Medical Sciences (NIGMS)
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of moderate/severe pain(>/= 4 of 10 using the Wong-Baker faces Scale) during recovery room stay | 0-8 hours postoperatively | Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients requiring analgesic intervention in the PACU will differ by BMI category (normal, overweight and obese). | 0-8 hours postoperatively | Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit. |
| Bivariate association between BMI (in Kg/m2) and serum values of inflammatory markers (CRP, TNF-alpha and IL-6) will be computed. | 0-8 hours postoperatively | Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit. |
Countries
United States
Outcome results
None listed