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Steroids and Pain Control After Tonsillectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995628
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Clarice Clemmens, MD, Medical University of South Carolina

Brief Summary:
This research study aims to find out if a single oral dose of steroid after tonsillectomy will reduce pain and decrease the need for narcotic medications.

Condition or disease Intervention/treatment Phase
Tonsillitis Obstructive Sleep Apnea of Child Drug: Dexamethasone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Trial of Post-operative Steroids and Pain Control After Tonsillectomy
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Experimental: Steroid Group
Participants will receive a one-time dose of oral dexamethasone at 0.5 mg/kg on the third post-operative day
Drug: Dexamethasone
One dose of dexamethasone (0.5 mg/kg) on post-operative day 3 after tonsillectomy
Other Name: Decadron

No Intervention: No Steroid Group
Participants will not receive dexamethasone



Primary Outcome Measures :
  1. Mean Visual Analog Score of Pain [ Time Frame: Postoperative day 6 ]
    On postoperative days 0-6, the caregiver assesses participant pain using The Faces Pain Scale-Revised, which measures pain via a visual analog score. The visual analog score is an integer value between 0-10, where 0 represents no pain and 10 represents maximum pain. The mean visual analog score on postoperative day 1-3 and the mean visual analog score on postoperative day 4-6 will be calculated for comparison between arms of the study. Lower mean visual analog scores on days 4-6 represent a better outcome.


Secondary Outcome Measures :
  1. Mean Opioid Consumption [ Time Frame: Postoperative day 6 ]
    The caregiver will keep a log of daily doses of opioids given to the participant for postoperative days 0-6. The mean total opioid consumption on postoperative day 1-3 and mean total opioid consumption on postoperative day 4-6 will be calculated for comparison between arms of the study.

  2. Mean NSAID and Acetaminophen Consumption [ Time Frame: Postoperative day 6 ]
    The caregiver will keep a log of daily doses of NSAIDs and/or acetaminophen given to the participant for postoperative days 0-6. The mean total NSAID and acetaminophen consumption on postoperative day 1-3 and on postoperative day 4-6 will be calculated for comparison between arms of the study.

  3. Rate of Nausea and Vomiting [ Time Frame: Postoperative day 6 ]
    The caregiver will keep a daily log of of the participant's nausea and vomiting status for postoperative days 0-6. The mean total instances of nausea and vomiting on postoperative day 1-3 and on postoperative day 4-6 will be calculated for comparison between arms of the study.

  4. Diet and Activity Levels [ Time Frame: Postoperative day 6 ]
    The caregiver will keep a daily log of of the participant's diet and activity levels for postoperative days 0-6. The mean diet and activity levels on postoperative day 1-3 and on postoperative day 4-6 will be calculated for comparison between arms of the study.

  5. Rate of 30-Day Readmission [ Time Frame: Postoperative day 30 ]
    A chart review will be performed to assess whether the participant ever needed to be readmitted to the hospital for postoperative complications, pain control, or dehydration due to poor oral intake within the first 30 days after surgery.

  6. Rate of 30-Day Emergency Room Visits [ Time Frame: Postoperative day 30 ]
    A chart review will be performed to assess whether the participant ever presented to the emergency room for postoperative complications, pain control, or dehydration due to poor oral intake within the first 30 days after surgery.

  7. Rate of Postoperative Oropharyngeal Hemorrhage [ Time Frame: Postoperative day 30 ]
    A chart review will be performed to assess whether postoperative oropharyngeal hemorrhage occurred in the 30 days following surgery.



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 3-12
  • Tonsillectomy with or without adenoidectomy for any indication
  • Outpatient (same day) surgery

Exclusion Criteria:

  • Bleeding disorder
  • Intra-operative surgical or anesthetic complication or unplanned admission
  • Pre-operative steroid use (defined as any steroid use greater than three days duration within 30 days prior to tonsillectomy)
  • Pre-operative opioid use (defined as any opioid use within 30 days prior to tonsillectomy)
  • Inability of parent/guardian to be contacted by phone for follow up
  • Inability or unwillingness of subject or legal guardian/representative to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995628


Contacts
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Contact: Michaela F Close, BS 802-920-9950 close@musc.edu
Contact: Joshua D Horton, MD 843-830-6271 hortojos@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Michaela F Close, BS    803-920-9950    close@musc.edu   
Contact: Joshua D Horton, MD    843-830-6271    hortojos@musc.edu   
Principal Investigator: Clarice S Clemmens, MD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Clarice S Clemmens, MD Medical University of South Carolina
Publications:

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Responsible Party: Clarice Clemmens, MD, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03995628    
Other Study ID Numbers: 00081346
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tonsillitis
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents