Dexamethasone and Post-tonsillectomy Pain in Children

Does Dexamethasone Reduce Postoperative Pain in Pediatric Tonsillectomy Patients?

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Post-tonsillectomy Pain
• Intervention / Treatment: Drug: Dexamethasone; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan C.S. Mott Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone; Liquid or capsule dexamethasone - to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy	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; Other Names: corticosteroid
Placebo Comparator: Placebo; Placebo liquid or capsule to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy	Drug: Placebo; Placebo liquid (Ora-sweet or simple syrup) or Placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of moderate/severe pain(>/= 4 of 10 using the Wong-Baker faces Scale) during recovery room stay	Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.	0-8 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients requiring analgesic intervention in the PACU will differ by BMI category (normal, overweight and obese).	Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.	0-8 hours postoperatively
Bivariate association between BMI (in Kg/m2) and serum values of inflammatory markers (CRP, TNF-alpha and IL-6) will be computed.	Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.	0-8 hours postoperatively

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Olubukola Nafiu, MD, University of Michigan, CS Mott Children's Hospital, Dept of Otolaryngology

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): June 27, 2019
• Study Completion (Actual): June 27, 2019

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 8, 2016

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: HUM00084860; 5K23GM104354 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO