Clinical trial NCT02793011: Dexamethasone and Post-tonsillectomy Pain in Children
Official title: Does Dexamethasone Reduce Postoperative Pain in Pediatric Tonsillectomy Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pediatric Post-tonsillectomy Pain
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2016-06-08
Enrollment: 137
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of moderate/severe pain(>/= 4 of 10 using the Wong-Baker faces Scale) during recovery room stay
timeFrame: 0-8 hours postoperatively
Secondary outcomes:
measure: Proportion of patients requiring analgesic intervention in the PACU will differ by BMI category (normal, overweight and obese).
timeFrame: 0-8 hours postoperatively
measure: Bivariate association between BMI (in Kg/m2) and serum values of inflammatory markers (CRP, TNF-alpha and IL-6) will be computed.
timeFrame: 0-8 hours postoperatively
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan C.S. Mott Children's Hospital
state: Michigan
Study officials:
affiliation: University of Michigan, CS Mott Children's Hospital, Dept of Otolaryngology
name: Olubukola Nafiu, MD
role: PRINCIPAL_INVESTIGATOR
References: