Does Dexamethasone Reduce Postoperative Pain in Pediatric Tonsillectomy Patients?
Overview
- Phase
- Phase 4
- Intervention
- Dexamethasone
- Conditions
- Pediatric Post-tonsillectomy Pain
- Sponsor
- Nationwide Children's Hospital
- Enrollment
- 137
- Locations
- 1
- Primary Endpoint
- Incidence of moderate/severe pain(>/= 4 of 10 using the Wong-Baker faces Scale) during recovery room stay
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Olubukola Nafiu
Assistant Professor of Anesthesiology, University of Michigan Medical School
University of Michigan
Eligibility Criteria
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
Arms & Interventions
Dexamethasone
Liquid or capsule dexamethasone - to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy
Intervention: Dexamethasone
Placebo
Placebo liquid or capsule to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence of moderate/severe pain(>/= 4 of 10 using the Wong-Baker faces Scale) during recovery room stay
Time Frame: 0-8 hours postoperatively
Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.
Secondary Outcomes
- 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)
- Proportion of patients requiring analgesic intervention in the PACU will differ by BMI category (normal, overweight and obese).(0-8 hours postoperatively)