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Dexamethasone for Tonsillar Bleeding (Blueberry Trial)
Blueberry Trial Summary
This trial found that a single dose of Dexamethasone given during surgery is not associated with an increased risk of postoperative bleeding in children undergoing tonsillectomy.
- Tonsillar Bleeding
- Postoperative Nausea and Vomiting
- Postoperative Pain
Blueberry Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2013 Phase 4 trial • 122 Patients • NCT01474915Blueberry Trial Design
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Who is running the clinical trial?
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- You are a child with a heart condition who takes aspirin or other blood thinners.
- Group 1: Sodium chloride
- Group 2: Dexamethasone
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What conditions are commonly alleviated with Dexamethasone?
"To combat elevated intra ocular pressure (iop), Dexamethasone is often prescribed. This medication can also be used to help patients manage symptoms related to ophthalmia, sympathetic inflammation, nasal irritation, and branch retinal vein occlusion."
How many individuals have been recruited for this research project?
"Indeed, the clinicaltrials.gov page for this trial confirms that it is actively seeking participants; first posted on November 1st 2020 and last updated on September 30th 2021, with a patient recruitment goal of 3794 across one site."
What other trials have utilized Dexamethasone to examine outcomes?
"Presently, 650 studies are being conducted regarding the medical efficacy of Dexamethasone. Of those active trials, 168 have reached Phase 3 testing. The majority of these research projects take place in Mishawaka, Indiana yet there are 19,031 other locations around the world also running such experiments."
What are the eligibility criteria for participation in this clinical experiment?
"In a trial of 3794 children aged from 2 to 13, those who have experienced postoperative pain are eligible for admission. Additional criteria that must be met include having had a tonsillectomy/tonsillotomy with or without adenoidectomy."
Is the participant age limit in this trial greater than twenty years?
"This medical study can accept patients that are between 2 and 13 years of age. A total of 230 studies have been conducted on minors and 1284 trials for seniors over the age 65."
Is there currently an opportunity available to join this research?
"Affirmative. Clinicaltrials.gov data confirms that the study, which was originally posted on November 1st 2020, is recruiting participants at present. The requirements are 3794 individuals from a single medical centre."
What potential ill effects could Dexamethasone pose for individuals?
"The safety rating of Dexamethasone stands at 3 due to the fact it has been approved by a phase 4 trial, thus having obtained adequate data demonstrating its efficacy."
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