Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT05507918 |
Other study ID # |
2022-017 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 2024 |
Est. completion date |
April 2025 |
Study information
Verified date |
April 2024 |
Source |
William Beaumont Hospitals |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Tonsillectomy is commonly described as one of the most painful procedures that an adult can
undergo. This study's aim is to evaluate if pre-operative oral hydration has an impact in
reducing post-operative pain, nausea and vomiting, and opioid medication use after adult
tonsillectomies. Participants will be randomized to a low, medium and high fluid intake
groups and will record fluid intake on the day before surgery. After surgery, participants
will record their pain and nausea at timepoints up to 7 days post-operative. Medication use
will be recorded up to the first post-operative follow-up visit with their physician.
Description:
Common indications for adult tonsillectomy include tonsillar hypertrophy, obstructive sleep
apnea, and chronic tonsillitis. Although there are many studies looking into how best to
prevent and treat post-operative pain and nausea, there are very few that give
recommendations to the patients pre-operatively. This study's aim is to evaluate if
pre-operative oral hydration has an impact in reducing post-operative pain, nausea and
vomiting after adult tonsillectomies. If pre-operative hydration can reduce the pain
associated with the procedure, then this could also be an adjunct to help reduce the amount
of narcotic pain medication that is required.
The goal of this study is to evaluate if the amount of pre-operative oral hydration can
reduce the amount of pain and nausea/vomiting in patients undergoing adult tonsillectomies.
This study will be measuring post-operative pain and nausea scores at several points after
the adult tonsillectomy procedure for participants that have consumed different amounts of
clear fluid in the 24 hours leading up to their nothing by mouth (NPO) status. Participants
will be randomized to one of three categories of preoperative fluid: 0.5 - 1.5 Liters (L),
1.5 - 3 L, and 3 - 4.5 L, which will correlate to the low, medium and high fluid intake
groups, respectively. Participants will be given a 1000 mL measuring water bottle that they
can use to accurately record their fluid consumption in the 24 hours prior to their
pre-operative NPO status. The fluid consumption that they record will include all liquids
(i.e., water, flavored water, juice, coffee, tea, soda, milk, alcohol). They will be asked to
keep a record of the volume of caffeinated beverage versus un-caffeinated beverages.
After surgery the participants will be given a form to record their pain and nausea scores.
Participants will record their pain and nausea by using two separate 10-point scales at 7
different points after the procedure. These scores will be measured immediately after
surgery, and at 4 hours, 8 hours, 24 hours, 72 hours, 5 days and 7 days postoperative. This
form, along with a count of opioid medication used, will be retuned to the physician at the
first post-operative follow-up visit.