NCT02793011

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2019

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

3.1 years

First QC Date

May 10, 2016

Last Update Submit

September 9, 2020

Conditions

Pediatric Post-tonsillectomy Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    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.

    0-8 hours postoperatively

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Liquid or capsule dexamethasone - to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Placebo liquid or capsule to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy

Drug: Placebo

Interventions

DexamethasoneDRUG

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

Also known as: corticosteroid
Dexamethasone
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Scheduled for tonsillectomy and/or adenoidectomy at University of Michigan, C. S. Mott Children's Hospital

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

DexamethasoneAdrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Olubukola Nafiu, MD

    University of Michigan, CS Mott Children's Hospital, Dept of Otolaryngology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology, University of Michigan Medical School

Study Record Dates

First Submitted

May 10, 2016

First Posted

June 8, 2016

Study Start

June 1, 2016

Primary Completion

June 27, 2019

Study Completion

June 27, 2019

Last Updated

September 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)