Dexamethasone and Post-tonsillectomy Pain in Children

Phase 4

Completed

• Conditions: Pediatric Post-tonsillectomy Pain
• Interventions: Drug: Dexamethasone; Drug: Placebo

• Registration Number: NCT02793011
• Lead Sponsor: Nationwide Children's Hospital

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.

Study Timeline

• Study First Submitted: 2016-05-10
• Study Start: 2016-06
• Study First Submitted QC: 2016-06-02
• Study First Posted: 2016-06-08
• Primary Completion: 2019-06-27
• Study Completion: 2019-06-27
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone	Liquid or capsule dexamethasone - to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy
Placebo	Placebo	Placebo liquid or capsule to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan C.S. Mott Children's Hospital; 🇺🇸 Ann Arbor, Michigan, United States