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Dexamethasone and Post-tonsillectomy Pain in Children

NCT02793011 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2020-09-10

No results posted yet for this study

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.

Conditions

  • Pediatric Post-tonsillectomy Pain

Interventions

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

DRUG

Placebo

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

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Olubukola Nafiu, MD · University of Michigan, CS Mott Children's Hospital, Dept of Otolaryngology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-06-27
Completion
2019-06-27

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02793011 on ClinicalTrials.gov