NCT02793011

Dexamethasone and Post-tonsillectomy Pain in Children

Does Dexamethasone Reduce Postoperative Pain in Pediatric Tonsillectomy Patients?

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Post-tonsillectomy Pain

Interventions

Type	Name	Description
DRUG	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
DRUG	Placebo	Placebo liquid (Ora-sweet or simple syrup) or Placebo capsule

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-06-27
• Completion: 2019-06-27
• First posted: 2016-06-08
• Last updated: 2020-09-10

Locations

1 site across 1 country: United States