Completed

NCT Number: NCT02793011

Dexamethasone and Post-tonsillectomy Pain in Children

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.

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Key information

Conditions

Pediatric Post-tonsillectomy Pain

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

About this study

(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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

Drug

Placebo liquid (Ora-sweet or simple syrup) or Placebo capsule

Primary outcomes

Incidence of moderate/severe pain(>/= 4 of 10 using the Wong-Baker faces Scale) during recovery room stay

Time frame: 0-8 hours postoperatively

Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.

Secondary outcomes

Proportion of patients requiring analgesic intervention in the PACU will differ by BMI category (normal, overweight and obese).

Time frame: 0-8 hours postoperatively

Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.
Bivariate association between BMI (in Kg/m2) and serum values of inflammatory markers (CRP, TNF-alpha and IL-6) will be computed.

Time frame: 0-8 hours postoperatively

Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Collaborators

National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Does Dexamethasone Reduce Postoperative Pain in Pediatric Tonsillectomy Patients?

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Jun 8, 2016
Registry last updated: Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.