Dexamethasone and Post-tonsillectomy Pain in Children

Nationwide Children's Hospital

Status and phase: Completed; Phase 4

Conditions: Pediatric Post-tonsillectomy Pain

Treatments: Drug: Dexamethasone; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02793011

HUM00084860

5K23GM104354 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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137 participants in 2 patient groups, including a placebo group

Dexamethasone

Experimental group

Description:

Liquid or capsule dexamethasone - to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy

Treatment:

Drug: Dexamethasone

Placebo

Placebo Comparator group

Description:

Placebo liquid or capsule to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy

Treatment:

Drug: Placebo