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Pre-Operative Hydration for Tonsillectomy Recovery
N/A
Waitlist Available
Led By Matthew Farrugia, DO
Research Sponsored by William Beaumont Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult undergoing primary tonsillectomy or any procedure which includes tonsillectomy as component at Beaumont Farmington Hills Hospital or Novi Surgery Center
Patients greater than or equal to 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 days postoperative
Awards & highlights
Study Summary
This trial looks at if drinking more before tonsillectomy can reduce post-op pain, nausea and opioid use. Participants will drink varying amounts and record their symptoms post-surgery.
Who is the study for?
This trial is for adults over 18 who are having their tonsils removed at specific centers and don't have chronic diseases like heart failure or diabetes. It's not for those allergic to pain meds, pregnant, on chronic pain meds, with a history of nausea from anesthesia, under 18, decisionally impaired, or with certain stomach issues.Check my eligibility
What is being tested?
The study tests if drinking more water and clear liquids before surgery can reduce throat pain, nausea, vomiting and the need for opioid painkillers after an adult tonsillectomy. Participants will be split into groups based on how much they drink before surgery and will track their symptoms for a week.See study design
What are the potential side effects?
Since this trial involves increased fluid intake rather than medication changes or new drugs, there aren't direct side effects being studied. However, participants may experience discomfort from consuming large amounts of liquid.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult getting my tonsils removed at Beaumont Farmington Hills Hospital or Novi Surgery Center.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 14 days postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 days postoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nausea 4 hours postoperative
Pain
Secondary outcome measures
Narcotic pain medication use after discharge
Narcotic pain medication use immediately following surgery
Nausea medication use after discharge
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Medium fluid intakeExperimental Treatment1 Intervention
1.5 L - 3 L fluid intake in the 24 hours prior to NPO status for surgery
Group II: Low fluid intakeExperimental Treatment1 Intervention
0.5 L - 1.5 L fluid intake in the 24 hours prior to NPO status for surgery
Group III: High fluid intakeExperimental Treatment1 Intervention
3 L - 4.5 L fluid intake in the 24 hours prior to NPO status for surgery
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Who is running the clinical trial?
William Beaumont HospitalsLead Sponsor
149 Previous Clinical Trials
112,529 Total Patients Enrolled
Matthew Farrugia, DOPrincipal InvestigatorBeaumont Health - Farmington Hills
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adult getting my tonsils removed at Beaumont Farmington Hills Hospital or Novi Surgery Center.I am on long-term pain, water pills, or steroid medications.You have experienced strong nausea or vomiting after being given anesthesia in the past.I am having my tonsils removed due to an abscess or cancer.I am allergic or cannot take acetaminophen or narcotic medications.I have a chronic condition like kidney disease, heart failure, diabetes, or chronic pain.I am 18 years old or older.I am under 18 years old.I am unable to make my own medical decisions.I have a history of serious stomach or esophagus problems.
Research Study Groups:
This trial has the following groups:- Group 1: Low fluid intake
- Group 2: Medium fluid intake
- Group 3: High fluid intake
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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