Dexamethasone and Post-tonsillectomy Pain in Children

• Status: Completed
• Trial end date: 2019-06-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nationwide Children's Hospital; University of Michigan
• Collaborator: National Institute of General Medical Sciences (NIGMS)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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